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.

Phase 3

• Conditions: Active, mild to moderate ulcerative colitis

• Registration Number: CTRI/2009/091/001004
• Lead Sponsor: Lupin Bioresearch Center Lupin Limited

Brief Summary

The study is a multi-center, double-blind, double-dummy, parallel group, placebo-controlled trial to evaluate therapeutic equivalence, efficacy and safety of generic Mesalamine (1200 mg x 2 tablets) Delayed Release tablets given once daily (test product of Sponsor) versus once-daily Lialda (1200 mg x 2 tablets) Delayed Release tablets (reference drug) and versus placebo, in 500 patients with mild to moderate ulcerative colitis. The study will be conducted in 36 centers across India. The primary outcome measure will be the percentage of patients in remission after 8 weeks of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-16
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 500

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

• ?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 within7 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).	8 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical improvement (drop in the UC-DAI greater than and equal to 3 points from baseline)	8 weeks
Change in UC-DAI score	8 weeks
Change in symptoms (rectal bleeding and stool frequency).	8 weeks
Change in endoscopic (mucosal) appearance	8 weeks

Trial Locations

Locations (35)

"Karnataka Gastroenterology Center; 🇮🇳 Bangalore, KARNATAKA, India

2nd Floor, Kamdhenu Complex Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Agrawal Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Amrita Institute of Medical Sciences and Research Centre; 🇮🇳 Elamakkara, PO,, India

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Chandramohan Clinic; 🇮🇳 Varanasi, UTTAR PRADESH, India

Choithram Hospital & Research Centre; 🇮🇳 Indore, MADHYA PRADESH, India

Citi Diagnostics; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

CN Gastro Care and Smile Dental Centre; 🇮🇳 Ashok, India

Dayanand Medical College and Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Scroll for more (25 remaining)

"Karnataka Gastroenterology Center

🇮🇳Bangalore, KARNATAKA, India

Dr. Umesh Jalihal

Principal investigator

91-9845136766

drumeshj@yahoo.co.in