Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT00317369
Status:
TERMINATED
Last Update Posted:
2021-02-15
First Post:
2006-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, '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': '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.', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'OPC-6535 25 mg', 'description': '25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'OPC-6535 50 mg', 'description': '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.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': '0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Anorectal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Postural dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Depressive symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Affect lability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Residual urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}], 'seriousEvents': [{'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-6535 25 mg', 'description': '25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}, {'id': 'OG001', 'title': 'OPC-6535 50 mg', 'description': '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.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '70.1'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '44.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': "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)", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Clinical Improvement Rate After 2 and 4 Weeks of Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-6535 25 mg', 'description': '25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}, {'id': 'OG001', 'title': 'OPC-6535 50 mg', 'description': '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.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '60.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '60.0'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '44.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, Week 4', 'description': '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)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-6535 25 mg', 'description': '25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}, {'id': 'OG001', 'title': 'OPC-6535 50 mg', 'description': '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.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '48.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '48.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '48.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, Week 4，Week 8', 'description': 'Definition of remission: Total CDAI score improved to below 150', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-6535 25 mg', 'description': '25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}, {'id': 'OG001', 'title': 'OPC-6535 50 mg', 'description': '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.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '65.2'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '60.0'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '44.5'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '65.2'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '60.0'}, {'value': '30.0', 'groupId': 'OG002', 'lowerLimit': '6.7', 'upperLimit': '65.2'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '65.2'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '70.1'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '55.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 2, 4, and 8', 'description': '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)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints.\n\nSubjects 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.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-6535 25 mg', 'description': '25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}, {'id': 'OG001', 'title': 'OPC-6535 50 mg', 'description': '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.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-19.4', 'spread': '46.5', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '57.9', 'groupId': 'OG001'}, {'value': '-8.8', 'spread': '25.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-17.1', 'spread': '77.6', 'groupId': 'OG000'}, {'value': '-22.1', 'spread': '78.2', 'groupId': 'OG001'}, {'value': '-23.5', 'spread': '32.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-30.3', 'spread': '60.3', 'groupId': 'OG000'}, {'value': '-32.3', 'spread': '80.4', 'groupId': 'OG001'}, {'value': '-31.2', 'spread': '51.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, and 8', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-6535 25 mg', 'description': '25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}, {'id': 'OG001', 'title': 'OPC-6535 50 mg', 'description': '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.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '17.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': "Mean Change From the Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score After 8 Weeks of Study Drug Administration", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-6535 25 mg', 'description': '25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}, {'id': 'OG001', 'title': 'OPC-6535 50 mg', 'description': '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.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Mean Change in C-reactive Protein (CRP) Level From the Baseline After 4 and 8 Weeks of Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OPC-6535 25 mg', 'description': '25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}, {'id': 'OG001', 'title': 'OPC-6535 50 mg', 'description': '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.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '2.06', 'groupId': 'OG001'}, {'value': '0.52', 'spread': '1.19', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '1.26', 'spread': '2.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4 and 8', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OPC-6535 25 mg', 'description': '25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}, {'id': 'FG001', 'title': 'OPC-6535 50 mg', 'description': '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.'}, {'id': 'FG002', 'title': 'Placebo', 'description': '0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'OPC-6535 25 mg', 'description': '25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}, {'id': 'BG001', 'title': 'OPC-6535 50 mg', 'description': '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.'}, {'id': 'BG002', 'title': 'Placebo', 'description': '0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '36.7', 'spread': '15.0', 'groupId': 'BG001'}, {'value': '33.4', 'spread': '6.3', 'groupId': 'BG002'}, {'value': '35.1', 'spread': '10.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'Efficacy was not cleared at US study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2006-04-21', 'resultsFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2006-04-21', 'lastUpdatePostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-26', 'studyFirstPostDateStruct': {'date': '2006-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration', 'timeFrame': 'Week 8', 'description': "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)"}], 'secondaryOutcomes': [{'measure': 'Clinical Improvement Rate After 2 and 4 Weeks of Study Drug Administration', 'timeFrame': 'Week 2, Week 4', 'description': '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)'}, {'measure': 'Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration', 'timeFrame': 'Week 2, Week 4，Week 8', 'description': 'Definition of remission: Total CDAI score improved to below 150'}, {'measure': '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', 'timeFrame': 'Baseline, Weeks 2, 4, and 8', 'description': '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)'}, {'measure': 'Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration', 'timeFrame': 'Baseline, Weeks 2, 4, and 8', 'description': '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.'}, {'measure': 'Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration', 'timeFrame': 'Baseline, Week 8', 'description': "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."}, {'measure': "Mean Change From the Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score After 8 Weeks of Study Drug Administration", 'timeFrame': 'Baseline, Week 8', 'description': '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.'}, {'measure': 'Mean Change in C-reactive Protein (CRP) Level From the Baseline After 4 and 8 Weeks of Study Drug Administration', 'timeFrame': 'Baseline, Weeks 4 and 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OPC-6535', "Crohn's disease"], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with active Crohn's disease\n* Patients who have a primary lesion in either the small intestine or the large intestine\n* Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose\n* Patients who have either never received enteral nutrition or have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less\n* Either inpatient or outpatient\n\nExclusion Criteria:\n\n* Patients who have an external fistula (including anal fistula) in which persistent drainage is observed (and who require treatment with antibiotics or synthetic antibacterial agents)\n* Patients with short bowel syndrome (and who require intravenous nutritional support due to insufficient intestinal nutrient uptake)\n* Patients with an artificial anus\n* Patients who have a complication of serious infectious disease (intra-abdominal abscess, etc.)\n* Patients who have a complication of malignant tumor\n* Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period"}, 'identificationModule': {'nctId': 'NCT00317369', 'briefTitle': "A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': "A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease", 'orgStudyIdInfo': {'id': '197-05-001'}, 'secondaryIdInfos': [{'id': 'JapicCTI-060217'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'OPC-6535(Tetomilast)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chubu Region', 'country': 'Japan'}, {'city': 'Chugoku Region', 'country': 'Japan'}, {'city': 'Hokkaido Region', 'country': 'Japan'}, {'city': 'Kanto Region', 'country': 'Japan'}, {'city': 'Kinki Region', 'country': 'Japan'}, {'city': 'Kyushu Region', 'country': 'Japan'}, {'city': 'Shikoku Region', 'country': 'Japan'}, {'city': 'Touhoku Region', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Katsuhisa Saito', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Study Director, Division of New Product Evaluation and Development'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}}}}