NCT00317356|TerminatedPhase 2Results
Study Stopped
Efficacy was not cleared at US study
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Efficacy was not cleared at US study
Sponsor study identifier
Secondary identifiers
interventional
43
1 country
8
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2007
Actual (reported)Study Completion
August 2007
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2007
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 21, 2006
Actual (reported)April 24, 2006
Actual (reported)May 2006
Date type not reportedThis date has not been verified as actual or estimated.
August 2007
Actual (reported)August 2007
Actual (reported)April 30, 2021
Actual (reported)Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration
Definition of clinical improvement: Disease Activity Index (DAI) subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline
Weeks 4 and 8
Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration
Weeks 4 and 8
Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration
Baseline, Weeks 4 and 8
Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
Baseline, Weeks 4 and 8
Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration
Baseline, Weeks 2, 4 and 8
Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration
Baseline and Week 8
Chubu Region, Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Shikoku Region, Japan
Touhoku Region, Japan
Katsuhisa Saito
Division of New Product Evaluation and Development
43 participants (actual enrollment reported by the registry).
First Submitted
April 21, 2006
First Posted
April 24, 2006
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Basiliximab in Moderate to Severe Ulcerative Colitis
Contact the study team to confirm eligibility.
Primary Completion
August 2007
Actual (reported)Study Completion
August 2007
Actual (reported)Last Updated
April 30, 2021
Results First Posted
April 30, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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