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 withUlcerative Colitis of the Rectum. - CESSA

Cristcot HCA LLC0 个研究点目标入组 618 人开始时间: 2021年6月17日最近更新: 2021年8月30日

适应症

试验速览

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•Male or non-pregnant, non-lactating females aged 18 years and older.
•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.
•Modified Mayo sub-score for stool frequency of 1-3.
•Modified Mayo sub-score for rectal bleeding of 0-2.
•Modified Mayo endoscopic sub-score of 2-3.
•Total 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

•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. Some medications to treat UC/irritable bowel syndrome (IBS) are prohibited during participation in the study. Prohibited medications include non-study corticosteroids, laxatives and antidiarrheal medications, and any medication delivered rectally (e.g., rectal 5-aminosalicylic acid [5-ASA medication]); however, oral 5-ASA agents at doses up to 4.8 g/day and daily fiber supplements are allowed. Subjects taking 5-ASA, and/or immunomodulatory agents will be stratified appropriately. Other medications (e.g., antibiotics, anti-seizure and anticoagulant medicines) are also prohibited.

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