Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories
Completed · Phase 3 · Has a placebo group
Conditions studied: Ulcerative Proctitis
In brief
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.
Key facts
- Study ID
- NCT04469686
- Run by
- Cristcot HCA LLC
- People needed
- 200
- Starts
- 2020-12-10
- Expected to finish
- 2024-09-19
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 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.
You may not qualify if…
- 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.
Where it is running
- Municipal non-profit enterprise "Kyiv City Clinical Hospital No. 18" of the executive body of the Kyiv City Council (Kyiv City State Administration) — Kyiv, Ukraine
- Comunal NonCommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital" — Lviv, Ukraine
- Municipal non-profit enterprise "Odesa Regional Clinical Hospital of the Odesa Regional Council", Regional Gastroenterological Center — Odesa, Ukraine
- Ternopil University Hospital — Ternopil, Ukraine
- Municipal non-profit enterprise "M.I. Pyrogov Vinnytsya Regional Clinical Hospital of the Vinnytsya Regional Council"; National Pirogov Memorial Medical University, Vinnytsya — Vinnytsia, Ukraine
- Municipal non-profit enterprise "Vinnytsya City Clinical Hospital №1"; National Pirogov Memorial Medical University, Vinnytsya — Vinnytsia, Ukraine
- Limited Liability Company "Medibor" — Zhytomyr, Ukraine
- 103 Military Hospital — Hanoi, Vietnam
- Bach Mai Hospital — Hanoi, Vietnam
- Hanoi Medical University Hospital — Hanoi, Vietnam
- Viet Duc Hospital — Hanoi, Vietnam
- Vinmec Hospital — Hanoi, Vietnam
- 115 People's Hospital — Ho Chi Minh City, Vietnam
- Cho Ray Hospital — Ho Chi Minh City, Vietnam
- Gia Dinh People's Hospital — Ho Chi Minh City, Vietnam
- Nguyen Tri Phuong Hospital — Ho Chi Minh City, Vietnam
- Hue Central Hospital — Huế, Vietnam
- Clinical Research Associates LLC — Huntsville, Alabama, United States
- Om Research — Apple Valley, California, United States
- Om Research — Camarillo, California, United States
- Precision Research — El Cajon, California, United States
- Om Research — Lancaster, California, United States
- Southern CA Research Institute Medical Group/W Gastroenterology Medical Group — Los Angeles, California, United States
- Cornell Medical Research — Newport Beach, California, United States
- Private Enterprise Private Manufacturing Company "Acinus" — Kropyvnytskyi, Ukraine
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.