NCT00073021已完成3 期
A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 386
- 试验地点
- 30
- 主要终点
- Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population
研究概览
简要总结
This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female between 18 and 75 years of age;
- •have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
- •currently demonstrating moderately active disease
排除标准
- •Patients will be excluded from admission to the study if they have/are:
- •a history of allergy or hypersensitivity to salicylates or aminosalicylates;
- •a history of extensive small bowel resection (>1/2 the length of the small intestine) causing short bowel syndrome;
- •current renal or hepatic disease;
- •participated in any drug or device clinical study within 30 days of entry;
- •currently enrolled in any other clinical study;
- •received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
- •received any other topical rectal therapy during the week prior to the Screening Visit;
- •received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
- •received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
- •received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
- •received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
- •if female, positive pregnancy test, or lactating.
研究组 & 干预措施
Asacol 2.4 g/day
Active Comparator
Asacol (2.4 g/day)
干预措施: Asacol 400 mg (mesalamine) (Drug)
Asacol 4.8 g/day
Experimental
Asacol (4.8 g/day)
干预措施: Asacol 800 mg (mesalamine) (Drug)
结局指标
主要结局
Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population
时间窗: 6 Weeks
Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment \[stool frequency, rectal bleeding, PFA, sigmoidoscopy\] and no worsening in any other clinical assessments)
次要结局
- Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population(6 weeks)
- Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population(6 Weeks)
- Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population(6 Weeks)
- Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6(6 Weeks)
- Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6(6 Weeks)
- Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6(6 Weeks)
- Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6(6 Weeks)
- Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients(3 Weeks)
- Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients(6 Weeks)
- Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients(6 Weeks)
- Percentage of Treatment Success Patients at Week 3, ITT Population(3 Weeks)
研究者
研究点 (30)
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