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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
Unnamed facility
Chubu Region, Japan
Unnamed facility
Chugoku Region, Japan
Unnamed facility
Hokkaido Region, Japan
Unnamed facility
Kanto Region, Japan
Unnamed facility
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
Time frame: 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
Definition of remission: DAI subscores for both rectal bleeding and mucosal appearance improved to 0
Time frame: Weeks 4 and 8
Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration
DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician's rating of disease activity. Each item of the score is assessed on a 4-point scale from 0 to 3; the total score ranges from 0 to 12 with a higher score representing greater severity. A negative change in mean score indicates improvement.
Time frame: Baseline, Weeks 4 and 8
Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
DAI measures disease activity through assessment of 4 items/subscales: stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician's rating of disease activity. Each item of the score is assessed on a 4-point scale from 0 to 3 with a higher score representing greater severity. A negative change in mean score indicates improvement.
Time frame: 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
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Kinki Region, Japan
Unnamed facility
Kyushu Region, Japan
Unnamed facility
Shikoku Region, Japan
Unnamed facility
Touhoku Region, Japan
CAI composed of 7 variables: number of stool weekly, blood in stools (weekly average), investigator's global assessment of symptomatic state, abdominal pain/cramps, temperature due to colitis, extraintestinal manifestations, and laboratory findings. The scores ranging from 0 to 29 points (higher scores meaning more severe disease).
Time frame: 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
The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of subjects with inflammatory bowel disease. The IBDQ score was calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions that address symptoms as a result of Crohn's disease: bowel symptoms, systemic symptoms, emotional function, and social function. Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL.
Time frame: Baseline and Week 8
Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration
The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of subjects with inflammatory bowel disease. The IBDQ includes 32 items, which are divided into four subscales: bowel symptoms, systemic symptoms, emotional function and social function, and each item is scored on a 7-point scale, ranging from 1 (worst) to 7 (best). Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL.
Time frame: Baseline and Week 8
Clinical Improvement Rate After 4 Weeks of Study Drug Administration
Definition of clinical improvement: DAI subscore for rectal bleeding improved to 0 or 1 and DAI subscore for mucosal appearance improved by at least 1 point from baseline
Time frame: Week 4