A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 2
- 主要终点
- Percentage of Patients Classified as Treatment Success at Week 6, ITT Population
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet
详细描述
This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of ulcerative colitis
排除标准
- •a history of allergy or hypersensitivity to salicylates or aminosalicylates;
- •a history of extensive small bowel resection
研究组 & 干预措施
1
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
干预措施: mesalamine (Drug)
2
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
干预措施: mesalamine (Drug)
结局指标
主要结局
Percentage of Patients Classified as Treatment Success at Week 6, ITT Population
时间窗: 6 weeks
Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA \[patient's functional assessment\], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments \[decrease of at least 1 on scale\] and no worsening \[no score increases\] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.
次要结局
- Percentage of Patients Classified as Treatment Success at Week 3, ITT Population(3 weeks)
- Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients(Week 3)
- Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients(Week 6)
- Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)(Week 3)
- Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)(Week 6)
- Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)(Week 3)
- Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)(Week 6)
- Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)(Week 3)
- Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)(Week 6)
- Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)(Week 3)
- Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)(Week 6)