Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis Remission

Trial Profile

Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis Remission

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Aug 2014

At a glance

  • Drugs Tetomilast (Primary) ; Mesalazine
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms CORE
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 12 May 2014 New trial record
    • 20 Jun 2007
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