EUCTR2019-003596-19-DE进行中（未招募）1 期
A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. - cessa
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 618
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects with a confirmed diagnosis of active UC of the rectum, extending no more than 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy performed at Visit 2. Note: Subjects may have a history of more extensive UC (e.g., pancolitis), but have active disease only in the rectum at the time of enrollment; Totaly modified Mayo Score (without physician global assessment) of 3-8
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 587
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •History or current diagnosis of bacterial or other infectious colitis, radiation-enteritis and radiation-proctitis, Crohn’s disease, collagenous colitis and indeterminate colitis; Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia; Concomitant active lower gastrointestinal disease (except IBS) or distortion of intestinal anatomy
研究者
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