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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-060217 |
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Efficacy was not cleared at US study
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The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) or in combination with a fixed oral dose of 5-ASA and enteral nutrition in patients with active Crohn's disease.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-6535(Tetomilast) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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: Total Crohn's Disease Activity Index (CDAI) score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease) | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement Rate After 2 and 4 Weeks of Study Drug Administration | Definition of clinical improvement: Total CDAI score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease) | Week 2, Week 4 |
| Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katsuhisa Saito | Study Director, Division of New Product Evaluation and Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | OPC-6535 25 mg | 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
| FG001 | OPC-6535 50 mg | 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks. |
| FG002 | Placebo | 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPC-6535 25 mg | 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
| BG001 | OPC-6535 50 mg | 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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: Total Crohn's Disease Activity Index (CDAI) score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease) | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
|
Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial.
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OPC-6535 25 mg | 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal fistula | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C108965 | tetomilast |
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Definition of remission: Total CDAI score improved to below 150 |
| Week 2, Week 4，Week 8 |
| Clinical Improvement Rate (50) by Change in Total CDAI Score (Number of Subjects for Each Change/Number of Subjects Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration | Definition of clinical improvement (50) : Total CDAI score improved by at least 50 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease) | Baseline, Weeks 2, 4, and 8 |
| Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration | CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity (CDAI < 150: Remission, CDAI > 450: Very severe). A negative change in mean score indicates improvement. | 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 patients 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. | Baseline, Week 8 |
| Mean Change From the Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score After 8 Weeks of Study Drug Administration | Large bowel endoscopic findings were assessed based on the CDEIS. The CDEIS considers deep ulcer, superficial ulcer, lesion ratio of , and ulcer ratio of the 5 pre-defined segments of the colon (small intestine, right colon, transverse colon, left colon, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe disease. | Baseline, Week 8 |
| Mean Change in C-reactive Protein (CRP) Level From the Baseline After 4 and 8 Weeks of Study Drug Administration | Baseline, Weeks 4 and 8 |
| Chugoku Region |
| Japan |
| Hokkaido Region | Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Touhoku Region | Japan |
| Withdrawal by Subject |
|
| BG002 | Placebo | 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | OPC-6535 50 mg | 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks. |
| OG002 | Placebo | 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
|
|
| Secondary | Clinical Improvement Rate After 2 and 4 Weeks of Study Drug Administration | Definition of clinical improvement: Total CDAI score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease) | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2, Week 4 |
|
|
|
| Secondary | Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration | Definition of remission: Total CDAI score improved to below 150 | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2, Week 4，Week 8 |
|
|
|
| Secondary | Clinical Improvement Rate (50) by Change in Total CDAI Score (Number of Subjects for Each Change/Number of Subjects Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration | Definition of clinical improvement (50) : Total CDAI score improved by at least 50 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease) | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Weeks 2, 4, and 8 |
|
|
|
| Secondary | Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration | CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity (CDAI < 150: Remission, CDAI > 450: Very severe). A negative change in mean score indicates improvement. | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 2, 4, and 8 |
|
|
|
| Secondary | 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 patients 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. | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
| Secondary | Mean Change From the Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score After 8 Weeks of Study Drug Administration | Large bowel endoscopic findings were assessed based on the CDEIS. The CDEIS considers deep ulcer, superficial ulcer, lesion ratio of , and ulcer ratio of the 5 pre-defined segments of the colon (small intestine, right colon, transverse colon, left colon, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe disease. | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
| Secondary | Mean Change in C-reactive Protein (CRP) Level From the Baseline After 4 and 8 Weeks of Study Drug Administration | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Weeks 4 and 8 |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 9 |
| 10 |
| EG001 | OPC-6535 50 mg | 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks. | 0 | 9 | 2 | 9 | 9 | 9 |
| EG002 | Placebo | 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks. | 0 | 10 | 0 | 10 | 8 | 10 |
| Subileus | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Anorectal disorder | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Postural dizziness | Nervous system disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Residual urine | Renal and urinary disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
Not provided
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| D007410 | Intestinal Diseases |
|
|
| Week 8 |
|
|
| Week 8 |
|
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| Week 8 |
|
|