Clinical Trial: An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
Brief Summary: The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).
Detailed Summary:
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Current Primary Outcome: Clinical improvement rate (Clinical improvement: a decrease of Disease Activity Index [DAI] score for "bloody stools" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "endoscopic findings" from the baseline) [ Time Frame: 6 weeks ]
Original Primary Outcome: Clinical improvement rate (Clinical improvement: a decrease of Disease Activity Index [DAI] score for "bloody stools" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "endoscopic findings" from the baseline)
Current Secondary Outcome:
- Clinical remission: a decrease of the total DAI scores for "bloody stools" and "endoscopic findings" to 0 points [ Time Frame: 6weeks ]
- Changes in the total DAI score [ Time Frame: 6 weeks ]
- Changes in each DAI subscore [ Time Frame: 2, 4, 6weeks ]
- Changes in the total Endoscopic Index (EI) score [ Time Frame: 6 weeks ]
- Changes in each EI subscore [ Time Frame: 6 weeks ]
Original Secondary Outcome:
- Clinical remission: a decrease of the total DAI scores for "bloody stools" and "endoscopic findings" to 0 points
- Changes in the total DAI score
- Changes in each DAI subscore
- Changes in the total Endoscopic Index (EI) score
- Changes in each EI subscore
Information By: Otsuka Pharmaceutical Co., Ltd.
Dates:
Date Received: April 19, 2007
Date Started: June 2007
Date Completion:
Last Updated: February 9, 2011
Last Verified: February 2011
