EUCTR2019-003596-19-BG招募中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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 199
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Subjects with a confirmed diagnosis of active UC of the rectum, Mayo Score of 2 or 3 extending no more than 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy performed at Visit 2 (Mayo Score of 0 or 1 above 15 cm is allowed). 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; Total modified Mayo Score (without physician global assessment) of 4-8
- •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 179
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •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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