A clinical trial to study the effects of Mesalamine Delayed Release tablets (1200mg x 2 tablets) in comparison with Lialda Delayed Release tablets (1200mg x 2 tablets) in patients with active, mild to moderate ulcerative colitis.
- Conditions
- Health Condition 1: null- Active, mild to moderate ulcerative colitis
- Registration Number
- CTRI/2009/091/001004
- Lead Sponsor
- upin Bioresearch Center Lupin Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 500
Male and female subjects between 18 and 60 years of age (both inclusive) with newly diagnosed or relapsing ( <6 weeks duration) mild to moderate ulcerative colitis (score of 4-10 [inclusive] on the UC-DAI scale with a sigmoidoscopy score of 1-2 and a Physician Global Assessment (PGA) of ≤2 with compatible histology.
?Severe disease as evidenced by the PGA, endoscopic score of ≥3, or experiencing a sustained relapse of >6 weeks.
?Pregnant or lactating females or females of childbearing age, not using reliable contraception.
?Relapse (<6 weeks duration) on maintenance therapy with doses of mesalamine >2 g/day or with a dose reduction of mesalamine from >2 g/day to <2 g/day or relapse unresponsive to steroids or mesalamine >2 g/day.
?History of hypersensitivity to sulfasalazine, mesalamine or its preparations, and salicylates.
?Crohn?s disease, proctitis, gastric outlet obstruction, bowel stricture, toxic megacolon, colonic dysplasia, colonic malignancies.
?History of intestinal resection (other than appendiceal resection), bleeding disorders, active peptic ulcer disease, or previous colonic surgery.
?Positive stool culture for pathogens (Salmonella, Shigella, Yersinia, Campylobacter, Listeria, and Clostridium difficile toxin) and positive stool examination for ova and parasites.
?Steroid or mesalamine enema within 14 days of the Baseline Visit.
?Treatment with systemic steroids, including adrenocorticotropic hormone (ACTH) within 30 days, or TNF-α inhibitor treatment within 90 days of the Baseline Visit.
?Intake of non-steroidal anti-inflammatory agents (NSAIDs), anti-diarrheals, laxatives, antibiotics, and anti-cholinergic agents within
7 days of the Baseline Visit.
?Uncontrolled hematological, renal, hepatic, metabolic, psychiatric, central nervous system (CNS), pulmonary or cardiovascular disease.
?Active malignancies, HIV, Hepatitis, A, B, C and E infections.
?Participation in a clinical trial within last 90 days, or currently in long-term follow-up for another clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission (defined as UC-DAI less than and equal to 1, stool frequency of 0, rectal bleeding of 0, and at least a 1-point reduction from baseline in an endoscopic score). <br/ ><br> <br/ ><br>Timepoint: 8 weeks
- Secondary Outcome Measures
Name Time Method Change in endoscopic (mucosal) appearanceTimepoint: 8 weeks;Change in symptoms (rectal bleeding and stool frequency).Timepoint: 8 weeks;Change in UC-DAI scoreTimepoint: 8 weeks;Clinical improvement (drop in the UC-DAI greater than and equal to 3 points from baseline)Timepoint: 8 weeks