CTRI/2009/091/001004Other3 期
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
Lupin Bioresearch Center Lupin Limited35 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年1月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 500
- 试验地点
- 35
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •?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.
结局指标
主要结局
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).
时间窗: 8 weeks
次要结局
- 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)
研究者
研究点 (35)
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