Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT01008618
Status:
COMPLETED
Last Update Posted:
2013-12-25
First Post:
2009-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Confirmatory Study of Fentanyl in Participants With Osteoarthritis or Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001416', 'term': 'Back Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1 609 730-3387', 'title': 'Director, Clinical Research', 'organization': 'Janssen Research & Development, L.L.C. USA'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Screening period up to the Follow-up period', 'eventGroups': [{'id': 'EG000', 'title': 'Fentanyl (Titration Period)', 'description': 'One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.', 'otherNumAtRisk': 218, 'otherNumAffected': 177, 'seriousNumAtRisk': 218, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Fentanyl (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.', 'otherNumAtRisk': 73, 'otherNumAffected': 50, 'seriousNumAtRisk': 73, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.', 'otherNumAtRisk': 77, 'otherNumAffected': 35, 'seriousNumAtRisk': 77, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Gastroenteritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Abnormal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Head discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Faeces hard', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 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'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Skeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}], 'seriousEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Positional vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Chronic heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Gastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Aspiration pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Lassitude', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The data was not estimable due to the high number of participants censored for this outcome measure.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The data was not estimable due to the high number of participants censored for this outcome measure.', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0846', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)', 'description': 'Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) population included all the randomly assigned participants with the exception of participants with pre-defined criteria.'}, {'type': 'SECONDARY', 'title': 'Pain Visual Analog Scale (VAS) Score - Titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Titration Period)', 'description': 'One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.'}], 'classes': [{'title': 'Last 3 days in Screening period (n=218)', 'categories': [{'measurements': [{'value': '74.1', 'spread': '12.37', 'groupId': 'OG000'}]}]}, {'title': 'Last 3 days in titration period (n=216)', 'categories': [{'measurements': [{'value': '39.71', 'spread': '21.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 12-14 (Screening period) and Day 27-29 (Titration period)', 'description': 'The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set in Period 1 (FAS1) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Pain Visual Analog Scale (VAS) Score - Double-Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}], 'classes': [{'title': 'Last 3 days in titration period (n=73, 77)', 'categories': [{'measurements': [{'value': '28.9', 'spread': '12.71', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '12.05', 'groupId': 'OG001'}]}]}, {'title': 'Last 3 days in double-blind period (n=72, 77)', 'categories': [{'measurements': [{'value': '28.9', 'spread': '18.99', 'groupId': 'OG000'}, {'value': '36.5', 'spread': '22.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 27-29 (Titration period) and Day 83-85 (double-blind period)', 'description': 'The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': "Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Titration Period)', 'description': 'One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.'}], 'classes': [{'title': 'Day 1, Category 1 (n=218)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Day 1, Category 2 (n=218)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Day 29/Final evaluation, Category 1 (n=218)', 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}]}]}, {'title': 'Day 29/ Final evaluation, Category 2 (n=218)', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and 29 or final evaluation (Titration period)', 'description': 'The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': "Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}], 'classes': [{'title': 'Day 1, Category 1 (n=73, 77)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, Category 2 (n=73, 77)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Day 85/Final evaluation, Category 1 (n=73, 77)', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Day 85/Final evaluation, Category 2 (n=73, 77)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and 85 or final evaluation (double-blind period)', 'description': 'The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Number of Doses of Rescue Treatment Per Day - Titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Titration Period)', 'description': 'One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.'}], 'classes': [{'title': 'Day 1 (n=218)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.19', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Day 29/Final evaluation (n=218)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and 29 or final evaluation (Titration period)', 'description': "If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.", 'unitOfMeasure': 'Treatments per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Number of Doses of Rescue Treatment Per Day - Double-Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}], 'classes': [{'title': 'Day 1 (n=73, 77)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.16', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0.0', 'spread': '0.11', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Day 85/Final evaluation (n=72, 77)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and 85 or final evaluation (double-blind period)', 'description': "If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.", 'unitOfMeasure': 'Treatments per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Titration Period)', 'description': 'One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.'}], 'classes': [{'title': 'Day 1 (n=218)', 'categories': [{'measurements': [{'value': '5.9', 'spread': '1.66', 'groupId': 'OG000'}]}]}, {'title': 'Day 29/Final evaluation (n=217)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and 29 or final evaluation (Titration period)', 'description': 'The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions \\[questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)\\]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 \\[questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)\\]). Total score ranges from 0 to 10 with higher values indicating more pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}], 'classes': [{'title': 'Day 1 (n=73, 77)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.66', 'groupId': 'OG001'}]}]}, {'title': 'Day 85/Final evaluation (n=73, 77)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and 85 or final evaluation (double-blind period)', 'description': 'The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions \\[questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)\\]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 \\[questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)\\]). Total score ranges from 0 to 10 with higher values indicating more pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Titration Period)', 'description': 'One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.'}], 'classes': [{'title': 'Day 1, Physical Component Score (n=218)', 'categories': [{'measurements': [{'value': '17.1', 'spread': '14.91', 'groupId': 'OG000'}]}]}, {'title': 'Day 1, Mental Component Score (n=218)', 'categories': [{'measurements': [{'value': '48.2', 'spread': '9.92', 'groupId': 'OG000'}]}]}, {'title': 'Day 29/Final, Physical Component Score (n=217)', 'categories': [{'measurements': [{'value': '23.3', 'spread': '15.56', 'groupId': 'OG000'}]}]}, {'title': 'Day 29/Final, Mental Component Score (n=217)', 'categories': [{'measurements': [{'value': '48.5', 'spread': '9.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and 29 or final evaluation (Titration period)', 'description': 'The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}], 'classes': [{'title': 'Day 1, Physical Component Score (n=73, 77)', 'categories': [{'measurements': [{'value': '25.8', 'spread': '14.71', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '14.30', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, Mental Component Score (n=73, 77)', 'categories': [{'measurements': [{'value': '50.1', 'spread': '8.29', 'groupId': 'OG000'}, {'value': '50.8', 'spread': '9.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 85/Final, Physical Component Score (n=73, 77)', 'categories': [{'measurements': [{'value': '24.3', 'spread': '16.11', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '14.64', 'groupId': 'OG001'}]}]}, {'title': 'Day 85/Final, Mental Component Score (n=73, 77)', 'categories': [{'measurements': [{'value': '49.9', 'spread': '9.82', 'groupId': 'OG000'}, {'value': '51.0', 'spread': '10.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and 85 or final evaluation (double-blind period)', 'description': 'The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': "Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Titration Period)', 'description': 'One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.'}], 'classes': [{'title': 'Effective', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}]}]}, {'title': 'Ineffective', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29 or final evaluation (Titration period)', 'description': "Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria.'}, {'type': 'SECONDARY', 'title': "Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}], 'classes': [{'title': 'Day 1, Effective (n= 73, 77)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, Ineffective (n= 73, 77)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 85/Final evaluation, Effective (n= 73, 77)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Day 85/Final evaluation, Ineffective (n= 73, 77)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and 85 or final evaluation (double-blind period)', 'description': "Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fentanyl (Titration Period)', 'description': 'One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.'}, {'id': 'FG001', 'title': 'Fentanyl (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}, {'id': 'FG002', 'title': 'Placebo (Double-blind Period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.'}], 'periods': [{'title': 'Period 1 (Titration Period)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Not satisfied criteria to enter Period 2', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Aggravated symptom', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (Double-Blind Period)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Insufficient analgesic efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'More than 3 times a day rescue treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'More than 15mm increase in Mean VAS', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'Not appropriate for this study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fentanyl (Titration Period)', 'description': 'One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '13.09', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '145', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-29', 'studyFirstSubmitDate': '2009-11-05', 'resultsFirstSubmitDate': '2013-03-20', 'studyFirstSubmitQcDate': '2009-11-05', 'lastUpdatePostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-03', 'studyFirstPostDateStruct': {'date': '2009-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy', 'timeFrame': 'Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)', 'description': 'Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.'}], 'secondaryOutcomes': [{'measure': 'Pain Visual Analog Scale (VAS) Score - Titration Period', 'timeFrame': 'Day 12-14 (Screening period) and Day 27-29 (Titration period)', 'description': 'The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported.'}, {'measure': 'Pain Visual Analog Scale (VAS) Score - Double-Blind Period', 'timeFrame': 'Day 27-29 (Titration period) and Day 83-85 (double-blind period)', 'description': 'The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported.'}, {'measure': "Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period", 'timeFrame': 'Day 1 and 29 or final evaluation (Titration period)', 'description': 'The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied".'}, {'measure': "Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period", 'timeFrame': 'Day 1 and 85 or final evaluation (double-blind period)', 'description': 'The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied".'}, {'measure': 'Number of Doses of Rescue Treatment Per Day - Titration Period', 'timeFrame': 'Day 1 and 29 or final evaluation (Titration period)', 'description': "If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported."}, {'measure': 'Number of Doses of Rescue Treatment Per Day - Double-Blind Period', 'timeFrame': 'Day 1 and 85 or final evaluation (double-blind period)', 'description': "If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported."}, {'measure': 'Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period', 'timeFrame': 'Day 1 and 29 or final evaluation (Titration period)', 'description': 'The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions \\[questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)\\]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 \\[questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)\\]). Total score ranges from 0 to 10 with higher values indicating more pain.'}, {'measure': 'Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period', 'timeFrame': 'Day 1 and 85 or final evaluation (double-blind period)', 'description': 'The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions \\[questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)\\]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 \\[questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)\\]). Total score ranges from 0 to 10 with higher values indicating more pain.'}, {'measure': 'Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period', 'timeFrame': 'Day 1 and 29 or final evaluation (Titration period)', 'description': 'The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.'}, {'measure': 'Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:', 'timeFrame': 'Day 1 and 85 or final evaluation (double-blind period)', 'description': 'The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.'}, {'measure': "Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period", 'timeFrame': 'Day 29 or final evaluation (Titration period)', 'description': "Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective."}, {'measure': "Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period", 'timeFrame': 'Day 1 and 85 or final evaluation (double-blind period)', 'description': "Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic pain', 'Osteoarthritis', 'Low back pain', 'Fentanyl', 'JNS020QD', 'Patch, transdermal', 'Opioid analgesics'], 'conditions': ['Chronic Pain', 'Osteoarthritis', 'Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '26359327', 'type': 'DERIVED', 'citation': 'Arai T, Kashimoto Y, Ukyo Y, Tominaga Y, Imanaka K. Two placebo-controlled, randomized withdrawal studies to evaluate the fentanyl 1 day patch in opioid-naive patients with chronic pain. Curr Med Res Opin. 2015 Dec;31(12):2207-18. doi: 10.1185/03007995.2015.1092127. Epub 2015 Oct 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy and safety of fentanyl in opioid-naive participants with osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) or low back pain who cannot obtain a sufficient analgesic effect by the treatment of non-opioid analgesics (drug used to control pain).', 'detailedDescription': "This is a multi-center (conducted in more than one center), double-blind (neither the participant nor the physician knows the assigned study drug), randomized (participants assigned study drug by chance), withdrawal study in opioid-naive participants with osteoarthritis or low back pain. The study will consist of titration period (10-29 days) and double-blind period (12 weeks) and the visits will include Day 5-7, 8, 15, 29 in titration period and Day 2-4, 8, 15, 22, 29, 43, 57, 71 and 85 in double-blind period. All the eligible participants will receive one-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) of either fentanyl at the dose ranging from 12.5 to 50 microgram per hour (mcg/hr) or matching placebo. Efficacy will be evaluated primarily by time to withdrawal due to insufficient analgesic efficacy. Participants' safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants whose pain because of osteoarthritis or low back pain is continuing for at least 12 weeks prior to informed consent\n* Participants who are continuously taking a non-opioid analgesic at the normal highest dose or more for at least 14 consecutive days prior to informed consent, or participant at a certain dose (except the use on an as-needed base) on consecutive days\n* Participants showing insufficient therapeutic efficacy of the non-opioid analgesic currently being used, and requiring a continuous opioid analgesic as per the investigator or sub-investigator\n* Participants with an average pain intensity of 50 millimeter or more on the Visual Analog Scale (VAS) in 24-hour daily living prior to informed consent\n* Participants who can be hospitalized to the 4th day after the initiation of titration period\n\nExclusion Criteria:\n\n* In cases of low back pain, participants with severe pain of lower extremities due to radiculopathy (a problem in which one or more nerves are affected) than that of low back pain, or participants with disc herniation (a medical condition affecting the spine due to trauma, lifting injuries, or idiopathic \\[unknown\\] causes) requiring an operation\n* In cases of low back pain, participants with pain due to compression fracture\n* Participants who had an operation that may affect the assessment within 30 days before informed consent\n* Participants whose main cause of the pain to be assessed is considered attributable to psychogenic pain (physical pain that is caused, increased, or prolonged by mental, emotional, or behavioral factors)\n* Participants with asthma, bradyarrhythmia (slow irregular heart beat) and severe respiratory function disorders'}, 'identificationModule': {'nctId': 'NCT01008618', 'briefTitle': 'A Confirmatory Study of Fentanyl in Participants With Osteoarthritis or Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Pharmaceutical K.K.'}, 'officialTitle': 'A Verification Study of JNS020QD in Patients With Osteoarthritis or Low Back Pain', 'orgStudyIdInfo': {'id': 'CR015541'}, 'secondaryIdInfos': [{'id': 'JNS020QD-JPN-N01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fentanyl (Titration period)', 'description': 'One-day adhesive transdermal patch containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which will be increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose will be increased up to maximum of 50 mcg/hr. The treatment will be continued for 10-29 days and then the eligible participants from this group will be randomly assigned to either of the two groups in the double-blind period.', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'EXPERIMENTAL', 'label': 'Fentanyl (Double-blind period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, will be administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which will be same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment will be continued for 12 weeks.', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Double-blind period)', 'description': 'Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, will be administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) will be gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo will be gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment will continue for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'description': 'One-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day.', 'armGroupLabels': ['Fentanyl (Double-blind period)', 'Fentanyl (Titration period)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo patch indistinguishable from one-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day.', 'armGroupLabels': ['Placebo (Double-blind period)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aki', 'country': 'Japan', 'geoPoint': {'lat': 33.5, 'lon': 133.9}}, {'city': 'Akō', 'country': 'Japan', 'geoPoint': {'lat': 35.55, 'lon': 137.25}}, {'city': 'Amagasaki', 'country': 'Japan', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'city': 'Anan', 'country': 'Japan', 'geoPoint': {'lat': 33.91667, 'lon': 134.65}}, {'city': 'Annaka', 'country': 'Japan', 'geoPoint': {'lat': 36.33011, 'lon': 138.89585}}, {'city': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chiisagata', 'country': 'Japan'}, {'city': 'Fuchū', 'country': 'Japan', 'geoPoint': {'lat': 35.67452, 'lon': 139.48216}}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuyama', 'country': 'Japan', 'geoPoint': {'lat': 34.48333, 'lon': 133.36667}}, {'city': 'Hamamatsu', 'country': 'Japan', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'city': 'Hiki', 'country': 'Japan', 'geoPoint': {'lat': 33.56534, 'lon': 135.44537}}, {'city': 'Himeji', 'country': 'Japan', 'geoPoint': {'lat': 34.81667, 'lon': 134.7}}, {'city': 'Hiratsuka', 'country': 'Japan', 'geoPoint': {'lat': 35.32785, 'lon': 139.33735}}, {'city': 'Hitachi-Naka', 'country': 'Japan', 'geoPoint': {'lat': 36.39659, 'lon': 140.53479}}, {'city': 'Ichikawa', 'country': 'Japan', 'geoPoint': {'lat': 35.73413, 'lon': 139.9065}}, {'city': 'Ikeda', 'country': 'Japan', 'geoPoint': {'lat': 34.82208, 'lon': 135.4298}}, {'city': 'Ikoma', 'country': 'Japan', 'geoPoint': {'lat': 34.68333, 'lon': 135.7}}, {'city': 'Itō', 'country': 'Japan', 'geoPoint': {'lat': 34.96667, 'lon': 139.08333}}, {'city': 'Izumo', 'country': 'Japan', 'geoPoint': {'lat': 35.36667, 'lon': 132.76667}}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kanazawa', 'country': 'Japan', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Kasama', 'country': 'Japan', 'geoPoint': {'lat': 36.38333, 'lon': 140.26667}}, {'city': 'Kitakyushu', 'country': 'Japan', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Kochi', 'country': 'Japan', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Koga', 'country': 'Japan', 'geoPoint': {'lat': 36.18333, 'lon': 139.71667}}, {'city': 'Komatsu', 'country': 'Japan', 'geoPoint': {'lat': 36.40263, 'lon': 136.45088}}, {'city': 'Kure', 'country': 'Japan', 'geoPoint': {'lat': 34.23222, 'lon': 132.56658}}, {'city': 'Kurume', 'country': 'Japan', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'city': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Maebaru', 'country': 'Japan', 'geoPoint': {'lat': 33.28037, 'lon': 131.10886}}, {'city': 'Matsudo', 'country': 'Japan', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'city': 'Matsumoto', 'country': 'Japan', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Miyazaki', 'country': 'Japan', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'city': 'Nagano', 'country': 'Japan', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Nagoya', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Niihama', 'country': 'Japan', 'geoPoint': {'lat': 33.96047, 'lon': 133.30522}}, {'city': 'Ohkawa', 'country': 'Japan'}, {'city': 'Ohmuta', 'country': 'Japan'}, {'city': 'Ohta-Ku', 'country': 'Japan'}, {'city': 'Ohtsu', 'country': 'Japan'}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Otaru', 'country': 'Japan', 'geoPoint': {'lat': 43.18944, 'lon': 141.00222}}, {'city': 'Ōita', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Saga', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'city': 'Sagamihara', 'country': 'Japan', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Sapporo', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sendai', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Suginami-Ku', 'country': 'Japan'}, {'city': 'Takaoka', 'country': 'Japan', 'geoPoint': {'lat': 36.75, 'lon': 137.01667}}, {'city': 'Takasaki', 'country': 'Japan', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'city': 'Takayama', 'country': 'Japan', 'geoPoint': {'lat': 36.13333, 'lon': 137.25}}, {'city': 'Tatebayashi', 'country': 'Japan', 'geoPoint': {'lat': 36.25, 'lon': 139.53333}}, {'city': 'Tokushima', 'country': 'Japan', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Toshima-Ku', 'country': 'Japan'}, {'city': 'Toyama', 'country': 'Japan', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Ube', 'country': 'Japan', 'geoPoint': {'lat': 33.94306, 'lon': 131.25111}}, {'city': 'Yokohama', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Janssen Pharmaceutical K.K., Japan Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Pharmaceutical K.K.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Pharmaceutical K.K.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}