Health Condition 1: null- Active, mild to moderate ulcerative colitis
Conditions
Interventions
Intervention1: Mesalamine Delayed Release 1200mg tablets of Lupin Ltd.: (1200 mg x 2 tablets) once-daily for 8 weeks
Control Intervention1: Placebo: 2 tablets once daily for 8 weeks
Control Interventi
Sponsors
Lupin Bioresearch Center Lupin Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: ? Severe disease as evidenced by the PGA, endoscopic score of &#8805;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-&#945; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactMs Arati Patil
Outcome results
None listed