Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories
NCT04469686 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-07-30
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.
Conditions
- Ulcerative Proctitis
Interventions
- 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
Sponsors & Collaborators
-
Cristcot HCA LLC
collaborator INDUSTRY -
Cristcot LLC
lead INDUSTRY
Principal Investigators
-
Jennifer Davagian · Cristcot LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-10
- Primary Completion
- 2024-07-16
- Completion
- 2024-09-19
- FDA Drug
- Yes
- FDA Device
- Yes
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
Study Locations
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