Status:
COMPLETED
Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories
Lead Sponsor:
Cristcot LLC
Collaborating Sponsors:
Cristcot HCA LLC
Conditions:
Ulcerative Proctitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 regi...
Detailed Description
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 hydrocortiso...
Eligibility Criteria
Inclusion
- 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 4-8.
Exclusion
- 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.
Key Trial Info
Start Date :
December 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04469686
Start Date
December 10 2020
End Date
September 19 2024
Last Update
July 30 2025
Active Locations (189)
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1
Clinical Research Associates LLC
Huntsville, Alabama, United States, 35801
2
Om Research
Apple Valley, California, United States, 92307
3
Om Research
Camarillo, California, United States, 93012
4
Precision Research
El Cajon, California, United States, 92020