Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 307
- 试验地点
- 14
- 主要终点
- Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1
研究概览
简要总结
To evaluate the safety and efficacy on clinical symptoms, mucosal histology and endoscopic mucosal appearance of two doses of SR140333B against placebo in patients with mild to moderate ulcerative colitis resistant to treatment with 5-ASA.
详细描述
Patients with active mild to moderate ulcerative colitis that has not responded to a minimum of 4 weeks of 5-ASA will be randomized to receive single daily doses of either placebo, 600 mg SR140333B or 1800 mg of SR140333B for eight weeks. Patients will undergo baseline and end of study sigmoidoscopic assessments and complete daily symptom diaries during the study. Ulcerative colitis disease activity will be measured by both the overall and component subscores of the Mayo Disease Activity Index.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 years
- •Ulcerative colitis of at least 6 months duration
- •Patient's ulcerative colitis should remain active while taking 5-ASA or sulfasalazine for at least 4 week
- •If taking corticosteroids, dose must be stable for at least 2 weeks prior to enrollment and not exceed 20 mg per day (prednisolone equivalent)
排除标准
- •Crohn's disease
- •Colonic dysplasia
- •Stool culture positive for enteric pathogens
- •Concurrent cancer or unstable medical condition
- •Recent treatment with monoclonal antibody
- •Recent introduction of thiazolidinedione
- •Recent treatment with methotrexate or cyclosporine
- •Recent treatment with an antibiotic prescribed for ulcerative colitis
结局指标
主要结局
Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1
次要结局
- Clinical response defined as at least 3 point reduction from baseline on Clinical Mayo Sub-score
- Global change in overall Disease Activity Index
- Abdominal pain score at 8 weeks
- Safety profile