3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Suppository Applicator in Subjects With Ulcerative Colitis of the Rectum
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 359
- 主要终点
- Clinical remission measured using the Modified Mayo Score
研究概览
简要总结
A randomized, multi-center, double-blind, three arm placebo-controlled study in male and non-pregnant, non-lactating female subjects aged 18 years to examine the safety and efficacy of two dosing regimens of hydrocortisone acetate 90 mg suppository administered with the Sephure suppository applicator for the treatment of ulcerative colitis of the rectum.
详细描述
Hydrocortisone acetate 90 mg or placebo will be administered as a rectal suppository with a Sephure suppository applicator. Two arms of the study will receive different dosage regimens of hydrocortisone acetate, and the third arm will receive placebo. All subjects will administer the study drug twice a day; once in the morning and once in the evening for 28 days.
The study population will consist of male and non pregnant, non lactating females aged 18 years and older with a confirmed diagnosis of active ulcerative colitis of the rectum.
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
- •Male or non pregnant, non lactating females aged 18 years and older.
- •Able to provide informed consent.
- •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
- •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.
- •Modified Mayo sub score for stool frequency of 1-
- •Modified Mayo sub score for rectal bleeding of 0-
- •Modified Mayo endoscopic sub score of 2-
- •Total Modified Mayo Score (without physician global assessment) of 4-8.
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 Irritable Bowel Syndrome) or distortion of intestinal anatomy.
- •Bleeding hemorrhoids at the time of enrollment.
- •Acute diverticulitis at the time of enrollment.
- •Acute or chronic pancreatitis at the time of enrollment.
- •Unmanaged celiac disease at the time of enrollment.
- •Positive stool test for enteric pathogens, Clostridium difficile, or presence of ova and parasites.
- •Taking a prohibited medication.
研究组 & 干预措施
Once Daily - Active
Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator
干预措施: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator (Combination Product)
Twice Daily - Active
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator
干预措施: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator (Combination Product)
Placebo
Twice daily placebo suppository administered with Sephure suppository applicator
干预措施: Twice daily placebo suppository administered with Sephure applicator (Combination Product)
结局指标
主要结局
Clinical remission measured using the Modified Mayo Score
时间窗: 28 days
To evaluate the the efficacy of two dosage regimens of the study drug
Clinical Remission
时间窗: 29 days
The primary efficacy endpoint was specified as the between-treatment group (HCA Suppository 90 mg bid versus placebo and HCA Suppository 90 mg qd versus placebo) difference in the proportion of subjects with clinical remission at the End of Treatment visit (Day 29). Clinical remission was defined as a Modified Mayo Total Score of 0 to 2, with stool frequency subscore of 0 or 1 (minimum 1 point decrease from baseline), rectal bleeding subscore of 0, and endoscopic subscore of 0 or 1.
次要结局
- Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0(28 days)
- Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency(28 days)
- Reduction of Stool Frequency(29 days)
- Rectal Bleeding(29 days)