A Phase 2 interventional study of OPC-6535(Tetomilast) in Colitis, Ulcerative, sponsored by Otsuka Pharmaceutical Co., Ltd.. Terminated at 8 sites in Japan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 43 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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
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
| Milestone | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo |
|---|---|---|---|---|
| Started | 11 | 11 | 10 | 11 |
| Completed | 10 | 9 | 9 | 8 |
| Not completed | 1 | 2 | 1 | 3 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 1 | 1 | 0 | 3 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 |
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
| percentage of participants | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo |
|---|---|---|---|---|
| Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration | 27.3 (6.0 to 61.0) | 30.0 (6.7 to 65.2) | 50.0 (18.7 to 81.3) | 9.1 (0.2 to 41.3) |
Definition of remission: DAI subscores for both rectal bleeding and mucosal appearance improved to 0
| percentage of participants | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo |
|---|---|---|---|---|
| Week 4 | 0.0 (0.0 to 30.8) | 0.0 (0.0 to 30.8) | 0.0 (0.0 to 36.9) | 9.1 (0.2 to 41.3) |
| Week 8 | 0.0 (0.0 to 28.5) | 9.1 (0.2 to 41.3) | 10.0 (0.3 to 44.5) | 9.1 (0.2 to 41.3) |
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.
| score on a scale | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo |
|---|---|---|---|---|
| Week 4 | -2.5 ± 2.4 | -1.0 ± 3.0 | -5.0 | -2.3 ± 4.2 |
| Week 8 | -2.6 ± 2.2 | -1.9 ± 3.4 | -3.8 ± 2.2 | -1.4 ± 2.3 |
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.
| score on a scale | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo |
|---|---|---|---|---|
| Rectal bleeding at Week 4 | -0.6 ± 0.8 | -1.0 ± 1.1 | -0.9 ± 0.7 | -0.4 ± 0.7 |
| Rectal bleeding at Week 8 | -0.7 ± 0.9 | -0.9 ± 1.1 | -1.1 ± 0.9 | -0.5 ± 0.7 |
| Mucosal appearance at Week 4 | -0.5 ± 0.6 | -0.3 ± 0.6 | -1.0 | -0.7 ± 1.2 |
| Mucosal appearance at Week 8 | -0.7 ± 0.7 | -0.5 ± 0.7 | -0.8 ± 0.7 | -0.3 ± 0.7 |
| Stool frequency at Week 4 | -0.4 ± 1.0 | -0.8 ± 1.2 | -0.8 ± 0.8 | -0.4 ± 0.7 |
| Stool frequency at Week 8 | -0.5 ± 1.1 | -0.3 ± 1.3 | -0.6 ± 0.7 | -0.4 ± 0.8 |
| Physician's rating of disease activity at Week 4 | -0.5 ± 0.7 | -0.7 ± 1.0 | -0.9 ± 0.7 | -0.4 ± 0.7 |
| Physician's rating of disease activity at Week 8 | -0.5 ± 0.5 | -0.5 ± 0.9 | -1.0 ± 0.7 | -0.2 ± 0.8 |
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).
| score on a scale | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo |
|---|---|---|---|---|
| Week 2 | -1.2 ± 3.1 | -2.4 ± 3.7 | -1.8 ± 1.5 | -1.0 ± 1.8 |
| Week 4 | -1.4 ± 2.3 | -2.6 ± 4.1 | -2.9 ± 2.3 | -1.1 ± 2.3 |
| Week 8 | -1.9 ± 2.2 | -2.6 ± 3.9 | -3.4 ± 2.5 | -1.0 ± 2.5 |
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.
| score on a scale | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo |
|---|---|---|---|---|
| Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration | 22.5 ± 26.5 | 7.1 ± 44.3 | 16.0 ± 40.2 | 9.3 ± 32.9 |
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.
| score on a scale | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo |
|---|---|---|---|---|
| Bowel symptoms at Week 8 | 9.3 ± 12.2 | 4.5 ± 18.6 | 5.8 ± 13.4 | 4.5 ± 11.0 |
| Systemic symptoms at Week 8 | 4.5 ± 5.6 | -1.1 ± 8.5 | 2.2 ± 7.0 | 0.0 ± 5.9 |
| Emotional function at Week 8 | 5.5 ± 8.6 | 1.2 ± 12.9 | 5.8 ± 15.0 | 4.0 ± 10.9 |
| Social function at Week 8 | 3.2 ± 6.1 | 2.5 ± 8.7 | 2.2 ± 7.2 | 0.7 ± 8.8 |
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
| percentage of participants | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo |
|---|---|---|---|---|
| Clinical Improvement Rate After 4 Weeks of Study Drug Administration | 12.5 (0.3 to 52.7) | 20.0 (0.5 to 71.6) | 14.3 (0.4 to 57.9) | 10.0 (0.3 to 44.5) |
Collected over Treatment period (8 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OPC-6535 12.5 mg | 0/11 (0%) | 0/11 (0%) | 6/11 (54.5%) |
| OPC-6535 25 mg | 0/11 (0%) | 2/11 (18.2%) | 7/11 (63.6%) |
| OPC-6535 50 mg | 0/10 (0%) | 2/10 (20%) | 7/10 (70%) |
| Placebo | 0/11 (0%) | 1/11 (9.1%) | 8/11 (72.7%) |
| Event | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo |
|---|---|---|---|---|
| Colitis ulcerativeGastrointestinal disorders | 0/11 | 2/11 | 2/10 | 1/11 |
| Event | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 0/11 | 4/11 | 2/10 | 1/11 |
| HeadacheNervous system disorders | 1/11 | 3/11 | 3/10 | 0/11 |
| Blood creatine phosphokinase increasedInvestigations | 0/11 | 0/11 | 1/10 | 3/11 |
| White blood cell count increasedInvestigations | 1/11 | 3/11 | 1/10 | 0/11 |
| Colitis ulcerativeGastrointestinal disorders | 0/11 | 0/11 | 0/10 | 2/11 |
| DiarrhoeaGastrointestinal disorders | 0/11 | 0/11 | 0/10 | 2/11 |
| VomitingGastrointestinal disorders | 0/11 | 2/11 | 1/10 | 0/11 |
| NasopharyngitisInfections and infestations | 1/11 | 1/11 | 0/10 | 2/11 |
| Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 2/11 | 1/11 | 0/10 | 0/11 |
| Blood potassium decreasedInvestigations | 0/11 | 1/11 | 1/10 | 0/11 |
| Age, Categorical(Participants) | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 1 | 1 |
| Between 18 and 65 years | 11 | 11 | 10 | 10 | 42 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo | Total |
|---|---|---|---|---|---|
| Female | 5 | 6 | 3 | 5 | 19 |
| Male | 6 | 5 | 7 | 6 | 24 |
| Race/Ethnicity, Customized(Participants) | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo | Total |
|---|---|---|---|---|---|
| Japanese | 11 | 11 | 10 | 11 | 43 |
| Region of Enrollment(Participants) | OPC-6535 12.5 mg | OPC-6535 25 mg | OPC-6535 50 mg | Placebo | Total |
|---|---|---|---|---|---|
| Japan | 11 | 11 | 10 | 11 | 43 |
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Otsuka Pharmaceutical Co., Ltd.