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

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.

Timeline

Start

2020-12-10

Primary completion

2024-07-16

Completion

2024-09-19

Drugs

Indications