drugset / Trial / NCT02368717

An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase

NCT02368717

Phase 3 Completed 281 enrolled Ferring Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to investigate the efficacy and safety of 4-week double-blind treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label extension phase with PENTASA enema and/or PENTASA tablets.

Timeline

Start
2015-03
Primary completion
2017-01-05
Completion
2017-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Mesalamine Small molecule Other

Indications