Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan

Summary

The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after 8-week treatment defined by a CDAI score of ≤ 150.

Timeline

Start

2012-02

Primary completion

2014-09

Completion

2014-09

Drugs

Indications