Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-060216 |
Not provided
Not provided
Not provided
Efficacy was not cleared at US study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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: 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Weeks 4 and 8 |
| Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katsuhisa Saito | Division of New Product Evaluation and Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | OPC-6535 12.5 mg | 12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
| FG001 | OPC-6535 25 mg | 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
| FG002 | OPC-6535 50 mg | 25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks. |
| FG003 | Placebo | 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OPC-6535 12.5 mg | 12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
| BG001 | OPC-6535 25 mg | 25 mg OPC-6535 orally administered once daily in the morning for 8 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: 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 | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 4 and 8 |
|
Treatment period (8 weeks)
Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints.
Not provided
| 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 12.5 mg | 12.5 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C108965 | tetomilast |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| 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. | 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). | 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. | 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. | 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 | Week 4 |
| Chugoku Region |
| Japan |
| Hokkaido Region | Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Touhoku Region | Japan |
| Lack of Efficacy |
|
| Physician Decision |
|
| BG002 | OPC-6535 50 mg | 25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks. |
| BG003 | Placebo | 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
25 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
| OG002 | OPC-6535 50 mg | 25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks. |
| OG003 | Placebo | 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks. |
|
|
| Secondary | 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 | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 4 and 8 |
|
|
|
| Secondary | 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. | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 4 and 8 |
|
|
|
| Secondary | 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. | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 4 and 8 |
|
|
|
| Secondary | 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). | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. | 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 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. | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 8 |
|
|
|
| Secondary | 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. | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 8 |
|
|
|
| Secondary | 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 | Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 6 |
| 11 |
| EG001 | OPC-6535 25 mg | 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks. | 0 | 11 | 2 | 11 | 7 | 11 |
| EG002 | OPC-6535 50 mg | 25 mg OPC-6535 orally administered for the first week and then the dose was increased to 50 mg for the following 7 weeks. | 0 | 10 | 2 | 10 | 7 | 10 |
| EG003 | Placebo | 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks. | 0 | 11 | 1 | 11 | 8 | 11 |
| Ear discomfort | Ear and labyrinth disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Feeling abnormal | General 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 |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Protein urine present | 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 |
|
| Headache | Nervous system disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 10.1 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | 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
Not provided
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| Week 8 |
|
|
| Week 8 |
|
|
|
| Rectal bleeding at Week 8 |
|
|
| Mucosal appearance at Week 4 |
|
|
| Mucosal appearance at Week 8 |
|
|
| Stool frequency at Week 4 |
|
|
| Stool frequency at Week 8 |
|
|
| Physician's rating of disease activity at Week 4 |
|
|
| Physician's rating of disease activity at Week 8 |
|
|
|
| Week 4 |
|
|
| Week 8 |
|
|
| Systemic symptoms at Week 8 |
|
| Emotional function at Week 8 |
|
| Social function at Week 8 |
|