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Mesalamine (5ASA; 5-aminosalicylic acid; Asacol; mesalazine; 5-ASA)

Alias: MAX-002; Z 206; 5 ASA; AJG 501; MAX 002;Mesalamine; 5-ASA; Mesalazine; 5-Aminosalicylic acid; Asacol; Z-206; AJG-501; Z206; 5ASA; 5-Amino-2-hydroxybenzoic acid; Pentasa; Asacol; Canasa; AJG501; MAX002
Cat No.:V0762 Purity: ≥98%
Mesalamine (also named as5ASA; Z-206; AJG-501; MAX-002; 5-aminosalicylic acid; Asacol;mesalazine; 5-ASA) is a specific and orally bioavailableinhibitor of TNFα-induced IKK activity with potential anti-inflammatory activity.
Mesalamine (5ASA; 5-aminosalicylic acid; Asacol; mesalazine; 5-ASA)
Mesalamine (5ASA; 5-aminosalicylic acid; Asacol; mesalazine; 5-ASA) Chemical Structure CAS No.: 89-57-6
Product category: IκB IKK
This product is for research use only, not for human use. We do not sell to patients.
Size Price Stock Qty
5g
10g
25g
50g
Other Sizes

Other Forms of Mesalamine (5ASA; 5-aminosalicylic acid; Asacol; mesalazine; 5-ASA):

  • 5-Aminosalicylic acid-d3
  • Mesalazine-d3 Hydrochloride
  • 5-Aminosalicylic acid-13C6
Official Supplier of:
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Purity & Quality Control Documentation

Purity: ≥98%

Product Description

Mesalamine (also named as 5ASA; Z-206; AJG-501; MAX-002; 5-aminosalicylic acid; Asacol; mesalazine; 5-ASA) orally bioavailable inhibitor of TNFα-induced IKK activity with potential anti-inflammatory activity. Additionally, it stimulates the PPARγ receptor and inhibits both NF-κB and p21-activated kinase 1 (PAK1). It has been approved for the treatment of ulcerative colitis, a type of inflammatory bowel disease.

Biological Activity I Assay Protocols (From Reference)
Targets
PPARγ; PAK1; p65
ln Vitro
5-Aminosalicylic acid (5-ASA) is a specific agonist for PPARγ, and only PPARγ but not PPARα or PPARδ induces p65 degradation. P65 protein is degraded by 5-aminosalicylic acid, demonstrating the E3 ubiquitin ligase activity of PPARγ. Additionally, PAK1 is inhibited by 5-aminosalicylic acid at the mRNA level, suggesting a second mechanism distinct from PPARγ ligand activation. Through PAK1 inhibition, 5-aminosalicylic acid prevents NF-κB from operating in intestinal epithelial cells (IECs). The growth of HT-29 colon carcinoma cells is inhibited by pretreatment with 5-Aminosalicylic acid (5-ASA) or nimesulide at various concentrations (10-1000 mol/L) for 12-96 h in a dose- and time-dependent manner. Nimesulide or 5-Aminosalicylic Acid's suppression, however, has no statistically significant effect. Pretreatment with varying doses of combined 5-Aminosalicylic acid and Nimesulide inhibits the growth of HT-29 colon carcinoma cells in a dose-dependent manner. A combination of 5-Aminosalicylic acid (final concentration 100 μM) and Nimesulide (final concentration 10-1000 μM) has a stronger inhibitory effect than a single dose of Nimesulide on the proliferation of HT-29 colon carcinoma cells. The proliferation of these cells is also inhibited by the combination of nimesulide (final concentration 100 μM) and 5-aminosalicylic acid (final concentration 10-1000 μM) in a dose-dependent manner[2].
ln Vivo
5-Aminosalicylic acid (5-ASA) has an antineoplastic effect in a xenograft tumor model. SCID mice engrafted with HT-29 colon cancer cells are given daily treatments for 21 days in a row with 5-Aminosalicylic acid at a concentration of 50 mM to assess the in vivo antineoplasic effect of the compound. Comparing SCID mice receiving 5-Aminosalicylic acid to control mice or mice receiving GW9662 alone at the end of the treatment, a reduction of 80–86% in tumor weight and volume is seen. After 10 days of treatment, the 5-Aminosalicylic Acid's anti-cancer effects are already apparent. Mice given 5-Aminosalicylic acid at 5 mM produced results that were similar. By simultaneously administering GW9662 intraperitoneally, 5-Aminosalicylic acid's antitumorigenic effect is completely eliminated at day 21.
Enzyme Assay
5-Aminosalicylic acid (Mesalamine) acts as a specific PPARγ agonist and also inhibits p21-activated kinase 1 (PAK1) and NF-κB.
Cell Assay
The MTT assay is used to measure cytostatic effects. A 0.25% trypsin solution is used to separate HT-29 colon cancer cells for 5 minutes. The cells are then seeded onto 96-well plates (1×106 cells/well), supplemented with 10% FCS, and given 24 hours to attach before test chemicals (5-Aminosalicylic acid 10, 50, 100, 500, and 1000 μM; Nimesulide; and their mixtures) are added. In a culture medium devoid of serum, test compounds are diluted. After 48 hours of incubation in a medium or with various drug concentrations, 20 μL of MTT solution (5 g/L) in PBS is added. After four hours, the medium in each well is taken out, and 120 L of muriatic isopropanol (0.04 mM) is added after being lightly concussed for ten minutes. Using an ELISA reader, dye uptake is measured at 490 nm. Each concentration or control group is divided into five wells. The cells, on the other hand, are seeded onto 96-well plates (1×106 cells/well) and allowed to adhere for 24 hours before being exposed to the test chemicals (5-Aminosalicylic acid, Nimesulide, and their combination). It has a 100 μM final concentration. The control group receives the identical medium after which dye uptake is assessed. For each test compound or control group, five wells are used[2].
Animal Protocol
Mice: Pathogen-free BALB/c SCID mice that are six to seven weeks old are used. Animals' flanks are implanted subcutaneously with 107 HT-29 human colon cancer cells, which have either been pretreated with GW9662 for 24 hours or not. Mice are given daily peritumoral injections of 5-Aminosalicylic Acid (5 or 50 mM) for 10 or 21 days starting two days after cell inoculation. By injecting GW9662 (1 mg/kg/day) intraperitoneally every day during treatment with 5-Aminosalicylic acid, the impact of PPAR is assessed. In the control group, 5-Aminosalicylic acid is substituted with saline. Three times per week, tumor development in mice is monitored. Tumor volume and size are determined after killing at 10 or 21 days. Prior to paraffin embedding for histological analysis, tumors are weighted.
ADME/Pharmacokinetics
Absorption, Distribution and Excretion
Depending on the formulation administered, prescribing information for orally administered delayed-released tablets of 2.4g or 4.8g of mesalazine given once daily for 14 days to healthy volunteers was to found to be about 21% to 22% of the administered dose while prescribing information for an orally administered controlled-release capsule formulation suggests 20% to 30% of the mesalazine in the formulation is absorbed. In contrast, when mesalamine is administered orally as an unformulated 1-g aqueous suspension, mesalazine is approximately 80% absorbed.
Elimination of mesalazine is mainly via the renal route following metabolism to N-acetyl-5-aminosalicylic acid (acetylation). However, there is also limited excretion of the parent mesalazine drug in the urine. After the oral administration of the extended-release formulation of mesalazine, of the approximately 21% to 22% of the drug absorbed, less than 8% of the dose was excreted unchanged in the urine after 24 hours, compared with greater than 13% for N-acetyl-5-aminosalicylic acid. When given the controlled-release formulation, about 130 mg free mesalazine was recovered in the feces following a single 1-g dose, which was comparable to the 140 mg of mesalazine recovered from the molar equivalent sulfasalazine tablet dose of 2.5 g F3001]. Elimination of free mesalazine and salicylates in feces increased proportionately with the dose given. N-acetylmesalazine was the primary compound excreted in the urine (19% to 30%) following the controlled-release dosing. In patients with ulcerative proctitis treated with mesalamine 500 mg as a rectal suppository every 8 hours for 6 days, 12% or less of the dose was eliminated in urine as unchanged 5-ASA and 8% to 77% was eliminated as N-acetyl-5-ASA following the initial dose. At steady state, 11% or less of the dose was eliminated in the urine as unchanged 5-ASA and 3% to 35% was eliminated as N-acetyl-5-ASA.
For the extended-release formulation, mesalazine has a Vd of 18 L, confirming minimal extravascular penetration of systemically available drug. For the delayed-release formulation, the apparent volume of distribution was estimated to be 4.8 L.
The mean (SD) renal clearance in L/h for mesalazine following the single dose administration of mesalazine delayed-release tablets 4.8g under fasting conditions to young and elderly subjects were documented as 2.05 ± 1.33 in young subjects aged 18 to 35 years old, 2.04 ± 1.16 in elderly subjects aged 65 to 75 years old and 2.13 ± 1.20 in elderly subjects older than 75 years.
Following oral administration, low concentrations of mesalamine and higher concentrations of its metabolite, N-acetyl-5-aminosalicylic acid, have been detected in human breast milk. It is not known whether mesalamine or its metabolites are distributed into milk in humans following rectal administration.
Mesalamine and N-acetyl-5-aminosalicylic acid cross the placenta following oral administration; however, serum concentrations of mesalamine in umbilical cord and amniotic fluid are very low. It is not known whether mesalamine crosses the placenta following rectal administration.
In vitro, mesalamine and N-acetyl-5-aminosalicylic acid are approximately 44-55 and 80% bound, respectively, to plasma proteins. Protein binding of N-acetyl-5-aminosalicylic acid does not appear to be concentration dependent at concentrations ranging from 1-10 ug/mL.
It is generally accepted that 5-aminosalicylate (5-ASA; mesalamine), widely used in inflammatory bowel disease therapy, exerts its action from the intraluminal site of the intestine. In addition to local metabolism of 5-ASA, it has been assumed that therapeutic mucosal concentrations of 5-ASA depend on transporter-mediated secretion back to the lumen. ... The hypothesis that 5-ASA represents a substrate of P-glycoprotein (P-gp) and/or multidrug resistance-associated protein 2 (MRP2), thereby possibly contributing to variable therapeutic effects /was tested/. Polarized, basal-to-apical transport of [(3)H]5-ASA was studied in monolayers of Caco-2 and L-MDR cells, both of which express P-gp in their apical membrane, as well as in MDCK cells transfected with human MRP2. Moreover, we investigated the influence of 5-ASA on transport of digoxin in Caco-2 cells. In Caco-2 cells a P-gp-mediated efflux of 5-ASA (5-500 muM) could be excluded. Likewise, in L-MDR1 and MRP2 cells no transport differences in either the basal-to-apical or apical-to-basal direction were measurable. 5-ASA (50 muM to 5 mM) had no effect on the transport of digoxin. ...
For more Absorption, Distribution and Excretion (Complete) data for MESALAMINE (15 total), please visit the HSDB record page.
Metabolism / Metabolites
Mesalazine is metabolized both pre-systemically by the intestinal mucosa and systemically in the liver to N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA) principally by NAT-1. Some acetylation also occurs through the action of colonic bacteria.
Mesalazine (5-aminosalicylic acid, 5-ASA), an anti-inflammatory agent for the treatment of inflammatory bowel diseases, is metabolized in organism to the principal biotransformation product, N-acetyl-5-ASA. Some other phase II metabolites (N-formyl-5-ASA, N-butyryl-5-ASA, N-beta-d-glucopyranosyl-5-ASA) have also been described. 5-ASA is a polar compound and besides it exhibits amphoteric properties. ...
The exact metabolic fate of mesalamine has not been clearly established. The drug undergoes rapid N-acetylation, probably in the liver, to form N-acetyl-5-aminosalicylic acid; mesalamine and N-acetyl-5-aminosalicylic acid also may undergo conjugation with glucuronic acid. Several other, unidentified metabolites also may be formed. It has been suggested that N-acetylation also may occur (to a limited extent) in the intestinal wall and/or the lumen. The intestinal flora probably are involved in this acetylation, and extensive floral acetylation may adversely affect clinical efficacy of the drug. Correlation between acetylator phenotype of patients receiving mesalamine and the degree of N-acetylation does not appear to exist. Although it has been suggested that N-acetyl-5-aminosalicylic acid may be pharmacologically active, therapeutic response has been poor in some patients treated rectally with this metabolite, and the relative contribution of this metabolite to the therapeutic effect of mesalamine remains questionable. N-Acetyl-5-aminosalicylic acid did not inhibit lipoxygenase in vitro.
Mesalazine has known human metabolites that include mesalazine, N-acetyl.
Biological Half-Life
For the delayed-release formulation, after intravenous administration, the elimination half-life of mesalamine is reported to be approximately 40 minutes. After oral dosing, the median terminal half life values for mesalamine are usually about 25 hours, but are variable, ranging from 1.5 to 296 hours. There is a large inter-subject and intra-subject variability in the plasma concentrations of mesalamine and N-acetyl-5-aminosalicylic acid and in their terminal half-lives following the administration of mesalazine. For the extended-release formulation, following single and multiple doses of mesalazine, the mean half-lives were 9 to 10 hours for 5-ASA, and 12 to 14 hours for N-Ac-5-ASA. The mean elimination half-life was 5 hours (CV=73%) for 5-ASA and 5 hours (CV=63%) for N-acetyl-5-ASA in patients taking 500 mg mesalazine as a rectal suppository every 8 hours for 6 days. For the rectal enema suspension formulation, the elimination half-life was 0.5 to 1.5 hours for 5-ASA and 5 to 10 hours for N-acetyl-5-ASA.
Elimination of metabolite: 5 to 10 hr /N-acetyl-5-aminosalicylci acid/
Elimination: 0.5-1.5 hours
Toxicity/Toxicokinetics
Interactions
Omeprazole may increase gastrointestinal pH; concurrent use may result in an increase in the absorption of mesalamine.
Acidification of the colonic lumen by lactulose may impair release of mesalamine from delayed- or extended-release formulations.
References

[1]. PAK1 modulates a PPARγ/NF-κB cascade in intestinal inflammation. Biochim Biophys Acta. 2015 Oct;1853(10 Pt A):2349-60.

[2]. The 5-aminosalicylic acid antineoplastic effect in the intestine is mediated by PPARγ. Carcinogenesis. 2013 Nov;34(11):2580-6.

[3]. 5-aminosalicylic acid in combination with Nimesulide inhibits proliferation of colon carcinoma cells in vitro. World J Gastroenterol. 2007 May 28;13(20):2872-7.

Additional Infomation
Therapeutic Uses
Mesalamine rectal suspension is indicated for the treatment of mild to moderate distal ulcerative colitis, proctosigmoiditis, and proctitis. /Included in US product labeling/
Mesalamine rectal suspension is indicated to help maintain remission of distal ulcerative colitis. /NOT included in US product labeling/
Mesalamine suppositories are indicated for the treatment of active ulcerative proctitis. /Included in US product labeling/
Mesalamine is indicated to treat and to maintain remission of mild to moderate ulcerative colitis or (Crohn's disease). /Included in US product labeling/
Lialda /the first oral once daily mesalamine tablet/ is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
Drug Warnings
Oral and rectal mesalamine preparations usually are well tolerated. The most common adverse effects of oral or rectal mesalamine are GI effects and headache. In clinical studies, most adverse effects associated with oral or rectal preparations were mild in severity and were transient or reversible. However, adverse effects have been severe enough to require discontinuance of the drug in less than 1% or in up to about 4-5% of patients receiving rectal or oral mesalamine, respectively, although in some studies, the rate of discontinuance of the drug was similar to or less than in those receiving placebo. Most of the adverse effects reported with the use of oral mesalamine delayed-release tablets were similar in short- and long-term studies.
Exacerbation of colitis symptoms was reported in 3% of patients receiving oral mesalamine delayed-release tablets. Other adverse GI effects associated with oral mesalamine extended-release capsules and occurring in less than 1% of patients, include abdominal distention, constipation, duodenal ulcer, dysphagia, eructation, esophageal or mouth ulcer, fecal incontinence, GI bleeding (e.g., rectal bleeding), stool abnormalities (e.g., change in color or texture), oral moniliasis, and thirst, although a causal relationship to the drug of many of these adverse effects has not been established.
In controlled clinical trials in patients receiving oral mesalamine delayed-release tablets, abdominal pain, eructation, nausea, diarrhea, dyspepsia, vomiting, constipation, flatulence, exacerbation of colitis, abdominal enlargement, gastroenteritis, GI hemorrhage, rectal disorder (e.g., hemorrhage, tenesmus), and stool abnormalities, were the most common adverse GI effects, occurring in about 2-18% of patients; dry mouth, indigestion, stomatitis, and cramping were reported rarely. Frequency of these GI effects did not seem to increase with increased dosages, although in uncontrolled studies, the incidence of abdominal pain, flatulence, and GI bleeding were dose related. The most common adverse GI effects of oral mesalamine extended-released capsules were diarrhea (including melena), nausea, abdominal pain, dyspepsia, vomiting, anorexia, worsening of ulcerative colitis, and rectal urgency, occurring in greater than 0.4-3% of patients.
An acute intolerance syndrome (sensitivity reaction), characterized by cramping, abdominal pain, bloody diarrhea, and, occasionally, fever, headache, malaise, conjunctivitis, pruritus, and rash, has occurred in a few patients receiving mesalamine and required prompt discontinuance of the drug. In patients manifesting such intolerance, a history of sulfasalazine intolerance, if any, should be reevaluated.
For more Drug Warnings (Complete) data for MESALAMINE (26 total), please visit the HSDB record page.
Pharmacodynamics
Mesalazine is one of the two components of sulphasalazine, the other being sulphapyridine. It is the latter responsible for most of the side effects associated with sulphasalazine therapy, while mesalazine is known to be the active moiety in the treatment of ulcerative colitis. Mesalazine is thought to dampen the inflammatory process through its ability to inhibit prostaglandin synthesis, interfere with leukotriene synthesis, and consequent leukocyte migration as well as act as a potent scavenger of free radicals. Regardless of the mode of action, mesalazine appears to be active mainly topically rather than systemically. Intraperitoneally administered mesalazine at 30 and 340 mg/kg daily had similar efficacy in attenuating colitis as prednisolone 4 to 550 mg/kg daily given intraperitoneally or sulphasalazine 0.34 to 5 mg/kg given orally in immune complex-induced colitis mice. Mesalazine at 5 mmol/L and sulphasalazine 1.5 mmol/L also reversed the increase in water and chloride secretion and decrease the sodium in dinitrochlorbenzene-induced colitis guinea pig.
These protocols are for reference only. InvivoChem does not independently validate these methods.
Physicochemical Properties
Molecular Formula
C7H7NO3
Molecular Weight
153.13
Exact Mass
153.042
Elemental Analysis
C, 54.90; H, 4.61; N, 9.15; O, 31.34
CAS #
89-57-6
Related CAS #
5-Aminosalicylic acid-d3;1309283-32-6;5-Aminosalicylic Acid-d3 hydrochloride;1346601-18-0;5-Aminosalicylic acid-13C6;1189709-96-3
PubChem CID
4075
Appearance
Brown to gray solid powder
Density
1.5±0.1 g/cm3
Boiling Point
380.8±32.0 °C at 760 mmHg
Melting Point
275-280 °C (dec.)(lit.)
Flash Point
184.1±25.1 °C
Vapour Pressure
0.0±0.9 mmHg at 25°C
Index of Refraction
1.691
LogP
1.14
Hydrogen Bond Donor Count
3
Hydrogen Bond Acceptor Count
4
Rotatable Bond Count
1
Heavy Atom Count
11
Complexity
160
Defined Atom Stereocenter Count
0
SMILES
O=C(C1C(O)=CC=C(N)C=1)O
InChi Key
KBOPZPXVLCULAV-UHFFFAOYSA-N
InChi Code
InChI=1S/C7H7NO3/c8-4-1-2-6(9)5(3-4)7(10)11/h1-3,9H,8H2,(H,10,11)
Chemical Name
5-amino-2-hydroxybenzoic acid
Synonyms
MAX-002; Z 206; 5 ASA; AJG 501; MAX 002;Mesalamine; 5-ASA; Mesalazine; 5-Aminosalicylic acid; Asacol; Z-206; AJG-501; Z206; 5ASA; 5-Amino-2-hydroxybenzoic acid; Pentasa; Asacol; Canasa; AJG501; MAX002
HS Tariff Code
2934.99.9001
Storage

Powder      -20°C    3 years

                     4°C     2 years

In solvent   -80°C    6 months

                  -20°C    1 month

Note: (1). This product requires protection from light (avoid light exposure) during transportation and storage.  (2). Please store this product in a sealed and protected environment (e.g. under nitrogen), avoid exposure to moisture.
Shipping Condition
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
Solubility Data
Solubility (In Vitro)
DMSO: ~31 mg/mL (~202.4 mM)
Water: <1 mg/mL
Ethanol: ~31 mg/mL (~202.4 mM)
Solubility (In Vivo)
Solubility in Formulation 1: ≥ 2.5 mg/mL (16.32 mM) (saturation unknown) in 10% DMSO + 40% PEG300 + 5% Tween80 + 45% Saline (add these co-solvents sequentially from left to right, and one by one), clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 25.0 mg/mL clear DMSO stock solution to 400 μL PEG300 and mix evenly; then add 50 μL Tween-80 to the above solution and mix evenly; then add 450 μL normal saline to adjust the volume to 1 mL.
Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH₂ O to obtain a clear solution.

Solubility in Formulation 2: ≥ 2.5 mg/mL (16.32 mM) (saturation unknown) in 10% DMSO + 90% (20% SBE-β-CD in Saline) (add these co-solvents sequentially from left to right, and one by one), clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of 25.0 mg/mL clear DMSO stock solution to 900 μL of 20% SBE-β-CD physiological saline solution and mix evenly.
Preparation of 20% SBE-β-CD in Saline (4°C,1 week): Dissolve 2 g SBE-β-CD in 10 mL saline to obtain a clear solution.

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Solubility in Formulation 3: 7.14 mg/mL (46.62 mM) in 50% PEG300 50% Saline (add these co-solvents sequentially from left to right, and one by one), suspension solution; with ultrasonication.
Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH₂ O to obtain a clear solution.


Solubility in Formulation 4: 16.67 mg/mL (108.85 mM) in 0.5% CMC-Na/saline water (add these co-solvents sequentially from left to right, and one by one), suspension solution; with ultrasonication.
Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH₂ O to obtain a clear solution.

 (Please use freshly prepared in vivo formulations for optimal results.)
Preparing Stock Solutions 1 mg 5 mg 10 mg
1 mM 6.5304 mL 32.6520 mL 65.3040 mL
5 mM 1.3061 mL 6.5304 mL 13.0608 mL
10 mM 0.6530 mL 3.2652 mL 6.5304 mL

*Note: Please select an appropriate solvent for the preparation of stock solution based on your experiment needs. For most products, DMSO can be used for preparing stock solutions (e.g. 5 mM, 10 mM, or 20 mM concentration); some products with high aqueous solubility may be dissolved in water directly. Solubility information is available at the above Solubility Data section. Once the stock solution is prepared, aliquot it to routine usage volumes and store at -20°C or -80°C. Avoid repeated freeze and thaw cycles.

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Clinical Trial Information
Therapeutic Effect of Methalazine on 27 Cases of Suppurative Hidradenitis
CTID: NCT06568224
Phase:    Status: Completed
Date: 2024-09-03
Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine
CTID: NCT06525974
PhaseEarly Phase 1    Status: Not yet recruiting
Date: 2024-07-29
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
CTID: NCT05663775
Phase: Phase 2    Status: Not yet recruiting
Date: 2024-06-12
Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis
CTID: NCT05781698
Phase: Phase 2    Status: Recruiting
Date: 2024-04-10
Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis
CTID: NCT05567068
Phase: Phase 2    Status: Recruiting
Date: 2024-04-10
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Fenofibrate in Ulcerative Colitis
CTID: NCT05753267
Phase: Phase 2/Phase 3    Status: Recruiting
Date: 2024-04-10


A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis
CTID: NCT05316220
Phase: Phase 3    Status: Not yet recruiting
Date: 2024-03-29
ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA
CTID: NCT05992142
Phase: Phase 4    Status: Completed
Date: 2024-03-21
Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis
CTID: NCT05119140
Phase: Phase 1/Phase 2    Status: Active, not recruiting
Date: 2024-03-04
Minocyclin in Ulcerative Colitis as Added on Therapy
CTID: NCT06201793
Phase: Phase 2    Status: Recruiting
Date: 2024-01-30
Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis.
CTID: NCT06176560
Phase: Phase 3    Status: Not yet recruiting
Date: 2023-12-19
Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis
CTID: NCT05205603
Phase: Phase 4    Status: Recruiting
Date: 2023-12-05
Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis
CTID: NCT04133194
Phase: Phase 4    Status: Recruiting
Date: 2023-09-26
Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease
CTID: NCT05986136
Phase: Phase 2/Phase 3    Status: Recruiting
Date: 2023-09-06
Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis
CTID: NCT05988528
Phase: Phase 2/Phase 3    Status: Recruiting
Date: 2023-08-23
Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis
CTID: NCT02537210
Phase: N/A    Status: Completed
Date: 2023-05-31
Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis
CTID: NCT03441893
Phase: Phase 1/Phase 2    Status: Active, not recruiting
Date: 2023-03-03
Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis
CTID: NCT05538026
Phase: N/A    Status: Completed
Date: 2022-09-13
Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment
CTID: NCT02261636
Phase:    Status: Completed
Date: 2022-05-20
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
CTID: NCT04920149
Phase: Phase 2    Status: Recruiting
Date: 2022-03-28
Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
CTID: NCT02522780
Phase: Phase 3    Status: Completed
Date: 2021-11-08
Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations
CTID: NCT00802451
Phase: N/A    Status: Completed
Date: 2021-10-15
Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).
CTID: NCT02665845
Phase: Phase 3    Status: Completed
Date: 2021-08-26
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
CTID: NCT00151892
Phase: Phase 3    Status: Completed
Date: 2021-06-14
Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis
CTID: NCT00548574
Phase: Phase 3    Status: Completed
Date: 2021-06-11
Taste Assessment Study of SHP429 in Healthy Adult Subjects
CTID: NCT02125292
Phase: Phase 1    Status: Completed
Date: 2021-06-03
Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
CTID: NCT02522767
Phase: Phase 3    Status: Completed
Date: 2021-03-15
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
CTID: NCT01412372
Phase: Phase 3    Status: Completed
Date: 2020-12-31
To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis
CTID: NCT03412682
Phase: Phase 3    Status: Completed
Date: 2020-06-18
The Colitis Once Daily Asacol Study
CTID: NCT00708656
Phase: Phase 3    Status: Completed
Date: 2020-01-30
Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)
CTID: NCT02280629
Phase: Phase 3    Status: Completed
Date: 2020-01-27
PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis
CTID: NCT03415711
Phase: N/A    Status: Terminated
Date: 2020-01-18
Mercaptopurine Therapy in Ulcerative Colitis
CTID: NCT02910245
Phase: Phase 3    Status: Unknown status
Date: 2020-01-07
PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers
CTID: NCT00622375
Phase: Phase 1    Status: Completed
Date: 2019-11-18
Predicting Response to Standardized Pediatric Colitis Therapy
CTID: NCT01536535
Phase: Phase 4    Status: Completed
Date: 2019-09-20
Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)
CTID: NCT01532648
Phase: Phase 3    Status: Completed
Date: 2019-09-06
Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
CTID: NCT01016262
Phase: Phase 3    Status: Terminated
Date: 2019-08-28
The Safety and Efficacy of TET Enema in the Treatment of UC
CTID: NCT03917095
Phase: N/A    Status: Unknown status
Date: 2019-05-15
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
CTID: NCT03070574
Phase: Phase 2    Status: Terminated
Date: 2019-04-18
Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients
CTID: NCT00349388
Phase: N/A    Status: Terminated
Date: 2019-01-29
Targeting Oxidative Stress in Chronic Beryllium Disease
CTID: NCT01088243
Phase: Phase 1/Phase 2    Status: Completed
Date: 2018-10-12
TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)
CTID: NCT01903252
Phase: Phase 3    Status: Completed
Date: 2018-08-08
QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)
CTID: NCT02368743
Phase:    Status: Completed
Date: 2018-07-05
Cimzia Versus Mesalamine for Crohn's Recurrence
CTID: NCT01696942
Phase: Phase 4    Status: Terminated
Date: 2018-01-12
Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis
CTID: NCT01209208
Phase: Phase 3    Status: Completed
Date: 2017-07-26
Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis
CTID: NCT00695643
Phase: Phase 3    Status: Terminated
Date: 2017-07-24
Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis
CTID: NCT01038739
Phase: Phase 3    Status: Terminated
Date: 2017-07-21
Medical Treatment of Colitis in Patients With Hermansky-Pudlak Syndrome
CTID: NCT00514982
Phase: Phase 2    Status: Withdrawn
Date: 2017-07-02
Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)
CTID: NCT00984568
Phase: Phase 3    Status: Terminated
Date: 2017-04-13
Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis
CTID: NCT03110198
Phase: Phase 4    Status: Unknown status
Date: 2017-04-12
Clinical Trial With Mesalamine 1g Suppositories
CTID: NCT01172444
Phase: Phase 3    Status: Terminated
Date: 2017-03-27
Mesalazine Treatment in IBS (The MIBS Study)
CTID: NCT01699438
Phase: Phase 2    Status: Completed
Date: 2017-02-24
Chemopreventive Action of Mesalazine on Colorectal Cancer: a Pilot Study for an 'in Vivo' Evaluation of the Molecular Effects on β-catenin Signaling Pathway.
CTID: NCT02077777
Phase: Phase 2    Status: Completed
Date: 2016-12-02
Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
CTID: NCT01514240
Phase: Phase 3    Status: Completed
Date: 2016-10-31
Canadian Active & Maintenance Modified Pentasa Study
CTID: NCT00603733
Phase: Phase 3    Status: Completed
Date: 2016-04-22
Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome
CTID: NCT02190526
Phase: Phase 4    Status: Withdrawn
Date: 2016-04-15
Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis
CTID: NCT02683759
Phase: Phase 3    Status: Unknown status
Date: 2016-02-23
Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis
CTID: NCT02683733
Phase: Phase 3    Status: Unknown status
Date: 2016-02-23
Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis
CTID: NCT01320436
Phase: Phase 3    Status: Completed
Date: 2016-02-12
OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis
CTID: NCT00449722
Phase: Phase 3    Status: Completed
Date: 2016-01-21
Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study
CTID: NCT01627262
Phase: Phase 2    Status: Completed
Date: 2016-01-21
Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis
CTID: NCT01201122
Phase: Phase 4    Status: Completed
Date: 2015-12-08
Mesalazine Effects in Sporadic Colorectal Adenoma Patients
CTID: NCT01894685
Phase: Phase 2    Status: Completed
Date: 2015-12-08
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
CTID: NCT00073021
Phase: Phase 3    Status: Completed
Date: 2015-06-29
Dose Escalation and Remission (DEAR)
CTID: NCT00652145
Phase: Phase 4    Status: Completed
Date: 2015-05-05
Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers
CTID: NCT02196662
Phase: Phase 1    Status: Completed
Date: 2015-04-22
Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease
CTID: NCT02335281
Phase: Phase 2    Status: Unknown status
Date: 2015-01-09
Evaluation of the Metabolome in Diverticular Disease
CTID: NCT01831323
Phase:    Status: Unknown status
Date: 2014-10-17
Mesalamine to Reduce T Cell Activation in HIV Infection
CTID: NCT01090102
Phase: Phase 4    Status: Completed
Date: 2014-08-13
Mesalamine in Environmental Enteropathy
CTID: NCT01841099
Phase: Phase 1/Phase 2    Status: Completed
Date: 2014-07-11
Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis
CTID: NCT00450086
Phase: Phase 3    Status: Completed
Date: 2014-05-19
Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)
CTID: NCT00300118
Phase: Phase 3    Status: Completed
Date: 2014-05-19
Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)
CTID: NCT01327300
Phase: Phase 2    Status: Completed
Date: 2014-02-12
Mesalazine for the Treatment of Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D)
CTID: NCT01316718
Phase: Phase 4    Status: Completed
Date: 2014-01-17
Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares
CTID: NCT01120340
Phase: Phase 3    Status: Completed
Date: 2013-09-18
Mesalazine Therapy in Patients With Irritable Bowel Syndrome
CTID: NCT00626288
Phase: Phase 3    Status: Completed
Date: 2013-07-26
Asacol Acute Diverticulitis(DIVA)Study
CTID: NCT00554099
Phase: Phase 2    Status: Completed
Date: 2013-04-22
Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers
CTID: NCT00751699
Phase: Phase 1    Status: Completed
Date: 2013-04-17
A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.
CTID: NCT00254618
Phase: Phase 1    Status: Terminated
Date: 2013-04-17
A Double Blind Study for the Treatment of Acute Ulcerative Colitis
CTID: NCT00350415
Phase: Phase 3    Status: Completed
Date: 2013-04-17
Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
CTID: NCT01257386
Phase: Phase 3    Status: Completed
Date: 2013-04-04
Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
CTID: NCT01257399
Phase: Phase 3    Status: Completed
Date: 2013-04-04
Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia
CTID: NCT01789294
Phase: Phase 4    Status: Unknown status
Date: 2013-02-12
Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis
CTID: NCT00343850
Phase: Phase 3    Status: Completed
Date: 2013-01-10
Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)
CTID: NCT00747110
Phase: Phase 3    Status: Completed
Date: 2012-06-26
Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine
CTID: NCT00946946
Phase: Phase 3    Status: Completed
Date: 2012-06-26
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
CTID: NCT01004185
Phase: Phase 3    Status: Terminated
Date: 2012-05-25
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
CTID: NCT00713310
Phase: Phase 3    Status: Completed
Date: 2012-04-05
A Study With Pentasa in Patients With Active Crohn's Disease
CTID: NCT00862121
Phase: Phase 3    Status: Terminated
Date: 2012-03-16
The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active 'Drug: Crohn's Disease'
CTID: NCT00245505
Phase: Phase 3    Status: Terminated
Date: 2012-03-12
Mesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon
CTID: NCT01534754
Phase: Phase 4    Status: Completed
Date: 2012-02-17
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
CTID: NCT00577473
Phase: Phase 3    Status: Completed
Date: 2011-09-16
Trial of Mesalamine for the Treatment of Active Microscopic Colitis
CTID: NCT00952952
Phase: Phase 2/Phase 3    Status: Completed
Date: 2011-05-24
Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
CTID: NCT00209300
Phase: Phase 3    Status: Completed
Date: 2011-05-19
Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
CTID: NCT01020708
Phase: Phase 1    Status: Completed
Date: 2011-03-29
A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis
CTID: NCT00808977
Phase: Phase 2    Status: Completed
Date: 2010-11-17
A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis
CTID: NCT01045018
Phase: Phase 3    Status: Completed
Date: 2010-01-08
A Randomized Controlled Pilot Trial of Mesalazine in Patients With Irritable Bowel Syndrome
CTID: NCT00774007
Phase: Phase 2/Phase 3    Status: Completed
Date: 2008-10-16
Asacol Dosing Study for Active Ulcerative Colitis
CTID: NCT00194818
Phase: Phase 4    Status: Completed
Date: 2008-02-15
Effect of an Anti-Inflammatory Drug on Gut Mucos
Adherence of a 1.600 mg single tablet 5-ASA treatment of Ulcerative colitis (EASI-trial)
CTID: null
Phase: Phase 4    Status: Ongoing
Date: 2019-09-05
Stopping Aminosalicylate Therapy in Inactive Crohn’s Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial
CTID: null
Phase: Phase 4    Status: GB - no longer in EU/EEA
Date: 2018-10-30
Drug disposition in the human colon: sampling optimization
CTID: null
Phase: Phase 4    Status: Completed
Date: 2018-01-09
Efficacy and safety of mesalazine, rifaximin, alone or as extemporary combination, in the treatment of symptomatic uncomplicated diverticular disease of colon: multi-centre, randomised, double-blind, double - dummy, parallel group, placebo-controlled study (MERISUDD study)
CTID: null
Phase: Phase 4    Status: Prematurely Ended
Date: 2017-10-12
Mesalamine for Colorectal Cancer Prevention Program in Lynch syndrome
CTID: null
Phase: Phase 2    Status: Prematurely Ended
Date: 2017-03-10
Intestinal mucosal concentrations from three mesalazine pharmaceutical formulations and correlation with efficacy in patients with mild/moderate ulcerative colitis
CTID: null
Phase: Phase 4    Status: Completed
Date: 2016-05-30
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis
CTID: null
Phase: Phase 3    Status: Completed
Date: 2015-12-07
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis
CTID: null
Phase: Phase 3    Status: Completed
Date: 2015-12-07
Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis
CTID: null
Phase: Phase 3    Status: Completed
Date: 2015-01-13
A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases
CTID: null
Phase: Phase 3    Status: Prematurely Ended, Completed
Date: 2014-10-22
Randomized, double-blind, multicentre study to compare the efficacy and safety of two different dosages of a novel budesonide suppository versus a mesalazine suppository versus a combination therapy of budesonide/mesalazine suppositories in patients with acute ulcerative proctitis
CTID: null
Phase: Phase 2    Status: Completed
Date: 2013-07-24
A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)
CTID: null
Phase: Phase 3    Status: Prematurely Ended, Completed
Date: 2013-06-28
Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis
CTID: null
Phase: Phase 3    Status: Completed
Date: 2013-01-15
A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis
CTID: null
Phase: Phase 1    Status: Completed
Date: 2013-01-04
Once versus twice daily mesalazine to introduce remission in pediatric ulcerative colitis: a randomized controlled trial
CTID: null
Phase: Phase 4    Status: Completed
Date: 2012-12-19
Mesapol: The effect of mesalazine on molecular pathways of cell
CTID: null
Phase: Phase 2    Status: Completed
Date: 2012-09-21
Mesacol: The effect of mesalazine on molecular pathways of
CTID: null
Phase: Phase 2    Status: Completed
Date: 2012-09-21
ND
CTID: null
Phase: Phase 2    Status: Completed
Date: 2012-05-02
A Randomised, Double Blind, Placebo Controlled, Multi-centre, Parallel Group, Interventional Study of Mesalazine (Asacol®) Treatment in IBS and the Evaluation of Rectal Inflammatory Status using the Mucosal Patch Technique
CTID: null
Phase: Phase 2    Status: Ongoing
Date: 2012-01-09
Chemopreventive effects of mesalazine in patients at high risk of recurrent (nonfamilial) colorectal adenomas
CTID: null
Phase: Phase 2    Status: Completed
Date: 2011-11-11
Efficacy and mode of action of mesalazine in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D).
CTID: null
Phase: Phase 4    Status: Completed
Date: 2010-11-25
Desensitisation of ulcerative colitis patients intolerant for mesalazine treatment.
CTID: null
Phase: Phase 4    Status: Ongoing
Date: 2010-11-08
A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate
CTID: null
Phase: Phase 4    Status: Completed
Date: 2010-06-30
Double-blind, dose-response, randomised, placebo-controlled, parallel group, multicentre phase III clinical study on the efficacy and tolerability of mesalazine granules vs. placebo for the prevention of recurrence of diverticulitis
CTID: null
Phase: Phase 3    Status: Prematurely Ended
Date: 2010-05-06
Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III study on the efficacy and tolerability of a 8-week treatment with 9 mg budesonide vs. 3 g mesalazine vs. placebo in patients with lymphocytic colitis
CTID: null
Phase: Phase 3    Status: Completed
Date: 2010-01-27
A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study
CTID: null
Phase: Phase 4    Status: Prematurely Ended
Date: 2009-10-26
Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:
CTID: null
Phase: Phase 2    Status: Ongoing
Date: 2009-09-08
Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553)
CTID: null
Phase: Phase 3    Status: Completed
Date: 2009-08-17
A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis
CTID: null
Phase: Phase 2    Status: Completed
Date: 2009-08-17
AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE
CTID: null
Phase: Phase 3    Status: Prematurely Ended
Date: 2009-03-24
PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo
CTID: null
Phase: Phase 3    Status: Prematurely Ended, Completed
Date: 2009-01-28
Evaluation of the role of mesalazine in the treatment of diverticular disease of the colon and irritable colon syndrome: A randomised double blind placebo controlled clinical study
CTID: null
Phase: Phase 3    Status: Ongoing
Date: 2008-12-15
A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis
CTID: null
Phase: Phase 2    Status: Completed
Date: 2008-12-02
Open label, uncontrolled pilot study on the effect of mucosal healing with 3 g mesalazine granules in NSAID induced small bowel enteropathy, evaluated by video capsule endoscopy after 4 weeks of treatment.
CTID: null
Phase: Phase 2    Status: Completed
Date: 2008-07-09
Multicentre, controlled, randomized, investigator-blinded, comparative study of oral
CTID: null
Phase: Phase 3    Status: Completed
Date: 2008-06-04
Evaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial
CTID: null
Phase: Phase 4    Status: Completed
Date: 2008-06-04
A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 versus Placebo over 104 weeks in the Prevention of Recurrence of Diverticulitis
CTID: null
Phase: Phase 3    Status: Completed
Date: 2008-05-20
A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 versus Placebo over 104 weeks in the Prevention of Recurrence of Diverticulitis
CTID: null
Phase: Phase 3    Status: Completed
Date: 2007-12-19
A randomised controlled multicenter trial assessing the efficacy and safety of mesalazine therapy in patients with irritable bowel syndrome.
CTID: null
Phase: Phase 3    Status: Ongoing
Date: 2007-11-08
Double-blind, randomized, placebo-controlled, parallel group, multi-centre phase III clinical study on the efficacy and tolerability of mesalazine granules vs. placebo for the prevention of recurrence of diverticulitis
CTID: null
Phase: Phase 3    Status: Completed
Date: 2007-10-29
Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis
CTID: null
Phase: Phase 3    Status: Completed, Prematurely Ended
Date: 2007-10-23
A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis
CTID: null
Phase: Phase 3    Status: Completed
Date: 2007-10-22
Mechanistic randomised contorlled trial of Mesalazine in symptomatic diverticular disease
CTID: null
Phase: Phase 4    Status: Completed
Date: 2007-07-23
Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules vs. mesalazine granules vs. placebo for patients with collagenous colitis
CTID: null
Phase: Phase 3    Status: Prematurely Ended, Completed
Date: 2007-03-15
Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease
CTID: null
Phase: Phase 2    Status: Prematurely Ended
Date: 2007-02-27
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