A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis.

Trial Profile

A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 May 2012

At a glance

  • Drugs Tetomilast (Primary)
  • Indications Ulcerative colitis
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 09 May 2012 Company (Otsuka Pharmaceutical Development and Commercialization) added as reported by ClinicalTrials.gov.
    • 09 May 2012 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health; NCT00064454).
    • 25 Aug 2011 Actual initiation date changed from 7 Sep 2005 to 24 Oct 2005 as reported by European Clinical Trials Database.
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