NCT04469686

Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories

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 Applicator in Subjects With Ulcerative Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Cristcot LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 regimens of hydrocortisone acetate 90 mg suppository administered with the Sephure applicator for the treatment of ulcerative colitis of the rectum.

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 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 UC of the rectum.

Conditions

• Ulcerative Proctitis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator	Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
COMBINATION_PRODUCT	Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator	Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
COMBINATION_PRODUCT	Twice daily placebo suppository administered with Sephure applicator	Twice daily placebo suppository administered with Sephure applicator

Timeline

• Start date: 2020-12-10
• Primary completion: 2024-07-16
• Completion: 2024-09-19
• First posted: 2020-07-14
• Last updated: 2025-07-30

Locations

189 sites across 23 countries: United States, Bulgaria, China, Denmark, France, Georgia, Germany, India, Italy, Jordan, Lebanon, Libya, Moldova, Philippines, Poland, Romania, Russia, Saudi Arabia, South Africa, Spain, Turkey (Türkiye), Ukraine, Vietnam

Regulatory

• FDA-regulated drug study
• FDA-regulated device study