Clinical Trial: A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

Brief Summary: The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.

Detailed Summary:
Sponsor: Otsuka Pharmaceutical Co., Ltd.

Current Primary Outcome: Clinical improvement rate (number of patients showing clinical improvement/number of patients evaluated x 100) after 8 weeks of study drug administration

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Remission rate (number of patients showing remission/number of patients evaluated x 100) after 4 and 8 weeks of study drug administration
  • Mean change from the baseline in total Disease Activity Index (DAI) score after 4 and 8 weeks of study drug administration
  • Mean change from the baseline in DAI subscores after 4 and 8 weeks of study drug administration
  • Mean change from the baseline in total Clinical Activity Index (CAI) score after 2, 4, and 8 weeks of study drug administration
  • Mean change from the baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score after 8 weeks of study drug administration
  • Mean change from the baseline in IBDQ subscale scores after 8 weeks of study drug administration
  • Clinical improvement rate after 4 weeks of study drug administration


Original Secondary Outcome:

  • Remission rate (number of patients showing remission/number of patients evaluated x 100) after 4 and 8 weeks of study drug administration
  • Mean change from the baseline in total DAI score after 4 and 8 weeks of study drug administration
  • Mean change from the baseline in DAI subscores after 4 and 8 weeks of study drug administration
  • Mean change from the baseline in total Clinical Activity Index (CAI) score after 2, 4, and 8 weeks of study drug administration
  • Mean change from the baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score after 8 weeks of study drug administration
  • Mean change from the baseline in IBDQ subscale scores after 8 weeks of study drug administration
  • Clinical improvement rate after 4 weeks of study drug administration


Information By: Otsuka Pharmaceutical Co., Ltd.

Dates:
Date Received: April 21, 2006
Date Started: May 2006
Date Completion:
Last Updated: April 28, 2008
Last Verified: April 2008