NCT00503243已完成3 期
A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Percentage of subjects in remission (Ulcerative Colitis Disease Activity Index score of <= 1, with scores of 0 for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline
研究概览
简要总结
The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily ([BID] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate 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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed or diagnosis of relapsing (relapsed <= 6 weeks to baseline) mild to moderate ulcerative colitis
- •women not of childbearing potential or WOCP who agreed to use an effective contraceptive method
排除标准
- •severe ulcerative colitis or relapsed for > 6 weeks prior to baseline
- •subjects who had relapsed on maintenance therapy with doses of mesalazine > 2.0 g/day
- •subjects with Crohn's disease, proctitis, bleeding disorders or active peptic ulcer disease
- •subjects with asthma if they were known to be mesalazine-sensitive
- •subjects who were at immediate or significant risk of toxic megacolon
- •subjects who had previous resective colonic surgery
- •subjects who had moderate or severe renal impairment
结局指标
主要结局
Percentage of subjects in remission (Ulcerative Colitis Disease Activity Index score of <= 1, with scores of 0 for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline
时间窗: 8 weeks
次要结局
- Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score(8 weeks)
- Change in symptoms (rectal bleeding and stool frequency)(2, 4 and 8 weeks)
- Change in sigmoidoscopic (mucosal) appearance(8 weeks)
- Change in the UC-DAI score(8 weeks)
- Time to withdrawal from the start of study medication(Throughout the study period of 8 weeks)
研究者
研究点 (1)
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