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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-090770 |
Not provided
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To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-6535 12.5mg | Experimental |
| |
| OPC-6535 25mg | Experimental |
| |
| OPC-6535 50mg | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tetomilast (OPC-6535) | Drug | oral administration of 12.5mg OPC-6535, once daily for 24months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months | Measurement over time (from baseline over the 24-month treatment period) and change from baseline to end of the treatment period. | Baseline, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at 24 Months in Total Symptom Diary Score | Subjects were required to keep a symptom diary throughout the entire trial period from the start of investigational medicinal product (IMP) administration in the washout period until the end of the treatment period. Assessment items included scores for shortness of breath, cough, and sputum, IMP compliance, use of salbutamol and respiratory symptom medications, and smoking status. Subjects recorded a score of between 0 and 3, with 0 indicating no symptoms and 3 indicating a high level of symptoms, for each domain. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central China Area | China | |||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | OPC-6535 12.5 mg | Oral administration of 12.5mg OPC-6535 once daily for 24 months |
| FG001 | OPC-6535 25 mg | Oral administration of 25mg OPC-6535 once daily for 24 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| tetomilast (OPC-6535) | Drug | oral administration of 25mg OPC-6535, once daily for 24months |
|
| tetomilast (OPC-6535) | Drug | oral administration of 50 mg OPC-6535, once daily for 24months |
|
| placebo | Drug | oral administration of placebo, once daily for 24months |
|
| Baseline, 24 months |
| Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score | The SGRQ is a self-administered questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being in three domains: symptoms, activity, and impact on daily life. The SGRQ was completed by each subject prior to IMP administration at baseline and at Month 6, Month 12, Month 18, and Month 24 (end of treatment). A weighted score based on population norms for each dimension and total was evaluated. Scores were expressed as a percentage of overall impairment where 100 represented worst possible health status and 0 indicated best possible health status. Scores were calculated when less than 24% of the item scores were missing, otherwise the scores were set to missing. Where there were multiple answers for a question, the worst case was used. | Baseline, 24 months |
| East China Area |
| China |
| North China Area | China |
| Northeast China Area | China |
| Northwest China Area | China |
| South China Area | China |
| Southwest China Area | China |
| Kansai Region, Et Al. | Japan |
| Seoul, Et Al. | South Korea |
| FG002 | OPC-6535 50 mg | Oral administration of 50 mg OPC-6535 once daily for 24 months (started from 25 mg for the first 2 weeks and the dose was titrated to 50 mg from the third week) |
| FG003 | Placebo | Oral administration of placebo once daily for 24 months |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population consisted all subjects randomized to double-blind therapy, regardless of any protocol violation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OPC-6535 12.5 mg | Oral administration of 12.5mg OPC-6535 once daily for 24 months |
| BG001 | OPC-6535 25 mg | Oral administration of 25mg OPC-6535 once daily for 24 months |
| BG002 | OPC-6535 50 mg | Oral administration of 50 mg OPC-6535 once daily for 24 months (started from 25 mg for the first 2 weeks and the dose was titrated to 50 mg from the third week) |
| BG003 | Placebo | Oral administration of placebo once daily for 24 months |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months | Measurement over time (from baseline over the 24-month treatment period) and change from baseline to end of the treatment period. | ITT population consisted of all subjects randomized to double-blind therapy, regardless of any protocol violation. | Posted | Mean | Standard Error | Liters | Baseline, 24 months |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at 24 Months in Total Symptom Diary Score | Subjects were required to keep a symptom diary throughout the entire trial period from the start of investigational medicinal product (IMP) administration in the washout period until the end of the treatment period. Assessment items included scores for shortness of breath, cough, and sputum, IMP compliance, use of salbutamol and respiratory symptom medications, and smoking status. Subjects recorded a score of between 0 and 3, with 0 indicating no symptoms and 3 indicating a high level of symptoms, for each domain. | ITT population consisted of all subjects randomized to double-blind therapy, regardless of any protocol violation. | Posted | Mean | Standard Error | score on a scale | Baseline, 24 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score | The SGRQ is a self-administered questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being in three domains: symptoms, activity, and impact on daily life. The SGRQ was completed by each subject prior to IMP administration at baseline and at Month 6, Month 12, Month 18, and Month 24 (end of treatment). A weighted score based on population norms for each dimension and total was evaluated. Scores were expressed as a percentage of overall impairment where 100 represented worst possible health status and 0 indicated best possible health status. Scores were calculated when less than 24% of the item scores were missing, otherwise the scores were set to missing. Where there were multiple answers for a question, the worst case was used. | ITT population consisted of all subjects randomized to double-blind therapy, regardless of any protocol violation. | Posted | Mean | Standard Error | score on a scale | Baseline, 24 months |
|
Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration until follow-up (2 weeks after the end of treatment or early termination)
Safety analyses were conducted on the safety population, defined all randomized subjects who took at least one dose of the IMP. A TEAE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the IMP, regardless of judgment of relationship to the IMP.
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 | Oral administration of 12.5mg OPC-6535 once daily for 24 months | 1 | 192 | 47 | 192 | 108 | 192 |
| EG001 | OPC-6535 25 mg | Oral administration of 25mg OPC-6535 once daily for 24 months | 5 | 196 | 47 | 196 | 116 | 196 |
| EG002 | OPC-6535 50 mg | Oral administration of 50 mg OPC-6535 once daily for 24 months (started from 25 mg for the first 2 weeks and the dose was titrated to 50 mg from the third week) | 3 | 191 | 50 | 191 | 102 | 191 |
| EG003 | Placebo | Oral administration of placebo once daily for 24 months | 2 | 190 | 46 | 190 | 105 | 190 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Herpes zoster infection neurological | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Pulmonary tuberculoma | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Astrocytoma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Chronic myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Head and neck cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Large cell lung cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Gingival cyst | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Traumatic liver injury | Injury, poisoning and procedural complications | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Cor pulmonale chronic | Cardiac disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Hypoxic encephalopathy | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Neuritis | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Spinal meningeal cyst | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Chondromalacia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Varicocele | Reproductive system and breast disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Computerised tomogram thorax abnormal | Investigations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Chronic granulomatous disease | Congenital, familial and genetic disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Dyssomnia | Psychiatric disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Ver. 12.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C108965 | tetomilast |
Not provided
Not provided
Not provided
| Male |
|
| Japan |
|
| China |
|
| OG003 | Placebo | Oral administration of placebo once daily for 24 months |
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|
Oral administration of 50 mg OPC-6535 once daily for 24 months (started from 25 mg for the first 2 weeks and the dose was titrated to 50 mg from the third week) |
| OG003 | Placebo | Oral administration of placebo once daily for 24 months |
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