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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 5:21 PM

Ignite Modification Date: 2026-01-01 @ 11:08 PM

Study NCT ID: NCT00917150

Status: COMPLETED

Last Update Posted: 2021-04-30

First Post: 2009-06-08

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108965', 'term': 'tetomilast'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CL_OPCJ_RDA_Team@otsuka.jp', 'phone': '+81-3-6361-7366', 'title': 'Director of Clinical Trials', 'organization': 'Otsuka Pharmaceutical Co., LTD.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '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)', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'OPC-6535 12.5 mg', 'description': 'Oral administration of 12.5mg OPC-6535 once daily for 24 months', 'otherNumAtRisk': 192, 'deathsNumAtRisk': 192, 'otherNumAffected': 108, 'seriousNumAtRisk': 192, 'deathsNumAffected': 1, 'seriousNumAffected': 47}, {'id': 'EG001', 'title': 'OPC-6535 25 mg', 'description': 'Oral administration of 25mg OPC-6535 once daily for 24 months', 'otherNumAtRisk': 196, 'deathsNumAtRisk': 196, 'otherNumAffected': 116, 'seriousNumAtRisk': 196, 'deathsNumAffected': 5, 'seriousNumAffected': 47}, {'id': 'EG002', 'title': 'OPC-6535 50 mg', 'description': '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)', 'otherNumAtRisk': 191, 'deathsNumAtRisk': 191, 'otherNumAffected': 102, 'seriousNumAtRisk': 191, 'deathsNumAffected': 3, 'seriousNumAffected': 50}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Oral administration of placebo once daily for 24 months', 'otherNumAtRisk': 190, 'deathsNumAtRisk': 190, 'otherNumAffected': 105, 'seriousNumAtRisk': 190, 'deathsNumAffected': 2, 'seriousNumAffected': 46}], 'otherEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 57}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Herpes zoster infection neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Pulmonary tuberculoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 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'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 12.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '149', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-6535 12.5 mg', 'description': 'Oral administration of 12.5mg OPC-6535 once daily for 24 months'}, {'id': 'OG001', 'title': 'OPC-6535 25 mg', 'description': 'Oral administration of 25mg OPC-6535 once daily for 24 months'}, {'id': 'OG002', 'title': 'OPC-6535 50 mg', 'description': '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)'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Oral administration of placebo once daily for 24 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.0481', 'groupId': 'OG000'}, {'value': '-0.023', 'spread': '0.0481', 'groupId': 'OG001'}, {'value': '-0.018', 'spread': '0.0473', 'groupId': 'OG002'}, {'value': '-0.035', 'spread': '0.0480', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 24 months', 'description': 'Measurement over time (from baseline over the 24-month treatment period) and change from baseline to end of the treatment period.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all subjects randomized to double-blind therapy, regardless of any protocol violation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at 24 Months in Total Symptom Diary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-6535 12.5 mg', 'description': 'Oral administration of 12.5mg OPC-6535 once daily for 24 months'}, {'id': 'OG001', 'title': 'OPC-6535 25 mg', 'description': 'Oral administration of 25mg OPC-6535 once daily for 24 months'}, {'id': 'OG002', 'title': 'OPC-6535 50 mg', 'description': '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)'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Oral administration of placebo once daily for 24 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.063', 'spread': '0.0606', 'groupId': 'OG000'}, {'value': '0.073', 'spread': '0.0606', 'groupId': 'OG001'}, {'value': '0.077', 'spread': '0.0597', 'groupId': 'OG002'}, {'value': '0.101', 'spread': '0.0606', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 24 months', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all subjects randomized to double-blind therapy, regardless of any protocol violation.'}, {'type': 'SECONDARY', 'title': "Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-6535 12.5 mg', 'description': 'Oral administration of 12.5mg OPC-6535 once daily for 24 months'}, {'id': 'OG001', 'title': 'OPC-6535 25 mg', 'description': 'Oral administration of 25mg OPC-6535 once daily for 24 months'}, {'id': 'OG002', 'title': 'OPC-6535 50 mg', 'description': '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)'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Oral administration of placebo once daily for 24 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.6', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '3.80', 'groupId': 'OG001'}, {'value': '-7.7', 'spread': '3.73', 'groupId': 'OG002'}, {'value': '-10.4', 'spread': '3.80', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 24 months', 'description': '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).\n\nA 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all subjects randomized to double-blind therapy, regardless of any protocol violation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OPC-6535 12.5 mg', 'description': 'Oral administration of 12.5mg OPC-6535 once daily for 24 months'}, {'id': 'FG001', 'title': 'OPC-6535 25 mg', 'description': 'Oral administration of 25mg OPC-6535 once daily for 24 months'}, {'id': 'FG002', 'title': 'OPC-6535 50 mg', 'description': '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)'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Oral administration of placebo once daily for 24 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '198'}, {'groupId': 'FG002', 'numSubjects': '191'}, {'groupId': 'FG003', 'numSubjects': '190'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '161'}, {'groupId': 'FG002', 'numSubjects': '149'}, {'groupId': 'FG003', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}, {'value': '190', 'groupId': 'BG003'}, {'value': '771', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'OPC-6535 12.5 mg', 'description': 'Oral administration of 12.5mg OPC-6535 once daily for 24 months'}, {'id': 'BG001', 'title': 'OPC-6535 25 mg', 'description': 'Oral administration of 25mg OPC-6535 once daily for 24 months'}, {'id': 'BG002', 'title': 'OPC-6535 50 mg', 'description': '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)'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Oral administration of placebo once daily for 24 months'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'spread': '7.63', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '7.01', 'groupId': 'BG001'}, {'value': '63.2', 'spread': '7.55', 'groupId': 'BG002'}, {'value': '63.4', 'spread': '7.24', 'groupId': 'BG003'}, {'value': '63.2', 'spread': '7.37', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}, {'value': '717', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '136', 'groupId': 'BG004'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '148', 'groupId': 'BG003'}, {'value': '590', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population consisted all subjects randomized to double-blind therapy, regardless of any protocol violation.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 771}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-05', 'studyFirstSubmitDate': '2009-06-08', 'resultsFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2009-06-09', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-05', 'studyFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1) Change From Baseline to 24 Months', 'timeFrame': 'Baseline, 24 months', 'description': 'Measurement over time (from baseline over the 24-month treatment period) and change from baseline to end of the treatment period.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline at 24 Months in Total Symptom Diary Score', 'timeFrame': 'Baseline, 24 months', 'description': '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.'}, {'measure': "Change From Baseline at 24 Months in St. George's Respiratory Questionnaire (SGRQ) Total Score", 'timeFrame': 'Baseline, 24 months', 'description': '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).\n\nA 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic obstructive pulmonary disease', 'COPD', 'emphysema'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40 to 75 years, inclusive, at the time informed consent is obtained\n* Ability to provide own written informed consent\n* Agree to use an appropriate method of contraception until 3 months after the last dose of the investigational medicinal product (IMP)\n* A rating of 1 or higher on the Goddard scale in assessment of emphysema severity by chest CT scan at screening\n* Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) of less than 70% at screening\n* Cigarette smoking history of at least 20 pack years at screening\n\nExclusion Criteria:\n\n* Subjects with obstructive disorders due to bronchial asthma\n* Subjects receiving long-term oxygen therapy\n* Subjects with active tuberculosis or obvious bronchiectasis\n* Complication of malignant tumor\n* Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders\n* Uncontrolled condition with COPD exacerbation of level 2 or 3 within 8 weeks prior to the start of washout period (within 12 weeks prior to start of treatment period)'}, 'identificationModule': {'nctId': 'NCT00917150', 'briefTitle': 'To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Dose-comparison Trial of OPC-6535 in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '197-08-801'}, 'secondaryIdInfos': [{'id': 'JapicCTI-090770'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OPC-6535 12.5mg', 'interventionNames': ['Drug: tetomilast (OPC-6535)']}, {'type': 'EXPERIMENTAL', 'label': 'OPC-6535 25mg', 'interventionNames': ['Drug: tetomilast (OPC-6535)']}, {'type': 'EXPERIMENTAL', 'label': 'OPC-6535 50mg', 'interventionNames': ['Drug: tetomilast (OPC-6535)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'tetomilast (OPC-6535)', 'type': 'DRUG', 'description': 'oral administration of 12.5mg OPC-6535, once daily for 24months', 'armGroupLabels': ['OPC-6535 12.5mg']}, {'name': 'tetomilast (OPC-6535)', 'type': 'DRUG', 'description': 'oral administration of 25mg OPC-6535, once daily for 24months', 'armGroupLabels': ['OPC-6535 25mg']}, {'name': 'tetomilast (OPC-6535)', 'type': 'DRUG', 'description': 'oral administration of 50 mg OPC-6535, once daily for 24months', 'armGroupLabels': ['OPC-6535 50mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'oral administration of placebo, once daily for 24months', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Central China Area', 'country': 'China'}, {'city': 'East China Area', 'country': 'China'}, {'city': 'North China Area', 'country': 'China'}, {'city': 'Northeast China Area', 'country': 'China'}, {'city': 'Northwest China Area', 'country': 'China'}, {'city': 'South China Area', 'country': 'China'}, {'city': 'Southwest China Area', 'country': 'China'}, {'city': 'Kansai Region, Et Al.', 'country': 'Japan'}, {'city': 'Seoul, Et Al.', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}