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.
A Phase III, Randomized, Multi-Centre, Double-Blind, Double-Dummy, Parallel Group, Placebo-Controlled Study to Evaluate Therapeutic Equivalence, Efficacy and Safety of Once-Daily Mesalamine 2400 mg (1200mg x 2 tablets) of Lupin Ltd., India, with Reference to Once-Daily LialdaTM (1200 mg x 2 Tablets) Delayed Release Tablets of Shire US Inc. in Subjects with Active, Mild to Moderate Ulcerative Colitis
Department of Gastroenterology, Institute of Post Graduate Medical Education and Research,244, Acharya Jagadish Chandra Bose Road-700020 Kolkata WEST BENGAL
Dr. Shyam Sunder Sharma
Sharma Gasteroenterolgy Centre
107, Guru Jhambeshwar Nagar ? A, Lane 3, Gandhi Path, Queens Road,-302021 Jaipur RAJASTHAN
+91-141-2358214
shyamsharma4@rediffmail.com
Dr. Rajiv Mehta
Shree Mahavir General Hospital
203, Liver Clinic, Near Kadiwala High School, Ring Road,- 395002 Surat GUJARAT
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.
ExclusionCriteria
Details
? 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.
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).
Total Sample Size="500" Sample Size from India="500" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
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.