NCT00548574已完成3 期
A Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With 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
- 343
- 试验地点
- 1
- 主要终点
- Percentage of subjects in remission (UC-DAI score <=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 primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of => 1 and a PGA <=2) with compatible histology
- •females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy test at screening and were on adequate contraception
排除标准
- •subjects with relapsing UC who were in relapse for > 6 weeks prior to baseline
- •subjects who relapsed on maintenace therapy with doses of mesalazine => 2g/day
- •subjects who had unsuccessfully treated their current relapse with steroids or a mesalazine dose of > 2g/day
- •subjects with Crohn's disease, proctitis, bleeding disorders, active peptic ulcer disease, previous colonic surgery, or those at an immediate risk of toxic megacolon or a stool culture positive for enteric pathogens
- •subjects who had used systemic or rectal steroids within the last 4 weeks, immunosuppressants wihtin the last 6 weeks or anti-inflammatory drugs on a repeat basis within 7 days prior to the baseline visit
- •subjects with hypersensitivity to salicylates and subjects with moderate/severe renal impairment
结局指标
主要结局
Percentage of subjects in remission (UC-DAI score <=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
- Treatment failure defined as unchanged, worsened missing or imcomplete UC-DAI score(8 weeks)
- Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score(8 weeks)
- Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score(8 weeks)
- Change from baseine in UC-DAI score, symptoms, sigmoidscopy score, and PGA(8 weeks)
研究者
研究点 (1)
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