Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT00531427
Status:
COMPLETED
Last Update Posted:
2012-09-10
First Post:
2007-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], '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': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-733-1333', 'title': 'Clinical Leader, Executive Medical Director', 'organization': 'Purdue Pharma'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after discontinuation; or Serious AEs occurring up to 30 days following the last study visit were followed until resolution or for up to 30 days.', 'description': 'AEs were obtained through spontaneous reports and subject interview.', 'eventGroups': [{'id': 'EG000', 'title': 'Double-blind BTDS', 'description': 'Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear', 'otherNumAtRisk': 282, 'otherNumAffected': 108, 'seriousNumAtRisk': 282, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Double-blind Placebo', 'description': 'Placebo patches to match the BTDS patches applied for 7-day wear', 'otherNumAtRisk': 285, 'otherNumAffected': 53, 'seriousNumAtRisk': 285, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Open-label Run-in Period', 'description': 'The open-label run-in period was designed with duration of time sufficient to select those subjects who both tolerated and responded to treatment with BTDS 10 or BTDS 20 (an enriched design). During this period, subjects were required to discontinue use of all nonstudy drugs used for the treatment of chronic pain and no supplemental analgesic medications were allowed. Subjects who did not tolerate BTDS 5 were discontinued from the study.', 'otherNumAtRisk': 1151, 'otherNumAffected': 520, 'seriousNumAtRisk': 1151, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Nausea', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 285, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numAffected': 242}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vomiting', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 285, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numAffected': 90}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Constipation', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 285, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numAffected': 90}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Application site pruritus', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 285, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numAffected': 96}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Application site erythema', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 285, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Application site rash', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 285, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Fatigue', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 285, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dizziness', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 285, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numAffected': 132}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Somnolence', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 285, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numAffected': 119}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Headache', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 285, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numAffected': 93}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Anxiety', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 285, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'seriousEvents': [{'term': 'Arteriosclerosis coronary artery - DEATH', 'notes': 'DEATH Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Atrial fibrillation', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Atrial flutter', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bradycardia', 'notes': 'Systematic and nonsystematic assessment One subject experienced bradycardia poststudy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Coronary artery disease', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Coronary artery stenosis', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypertensive heart disease - DEATH', 'notes': 'DEATH Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Myocardial infarction', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vertigo', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vomiting', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal pain', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nausea', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Chest pain', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Noncardiac chest pain', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cardiac procedure complications', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Collapse of lung', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Drug hypersensitivity', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Blood pressure increased', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Endometrial cancer', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dizziness', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Syncope', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Alcoholism', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Disorientation', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Deep vein thrombosis', 'notes': 'Systematic and nonsystematic assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Acute myocardial infarction', 'notes': 'Systematic and nonsystematic assessments One subject experienced acute myocardial infarction poststudy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Atrioventricular block second degree', 'notes': 'Poststudy SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Small cell lung cancer metastatic', 'notes': 'Poststudy SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Fall', 'notes': 'Poststudy SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hip fracture', 'notes': 'Poststudy SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '4.50'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '"Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind BTDS 10 or 20', 'description': 'Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo patches to match the BTDS patches applied for 7-day wear'}], 'classes': [{'title': 'Screening (Visit 2)', 'categories': [{'measurements': [{'value': '7.16', 'spread': '1.340', 'groupId': 'OG000'}, {'value': '7.06', 'spread': '1.300', 'groupId': 'OG001'}]}]}, {'title': 'Prerandomization (Visit 3)', 'categories': [{'measurements': [{'value': '2.63', 'spread': '1.292', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '1.186', 'groupId': 'OG001'}]}]}, {'title': 'Double-blind Week 12 (Visit 8)', 'categories': [{'measurements': [{'value': '3.82', 'spread': '2.644', 'groupId': 'OG000'}, {'value': '4.22', 'spread': '2.644', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0853', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.05', 'groupDescription': '\\[Week 12 analysis\\] The null hypothesis was "no group differences." The alternative hypothesis was that BTDS arm was superior to the placebo arm.\n\nPain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Statistics are based on a mixed effect general linear model', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24 hours (week 12)', 'description': '"Average pain over the last 24 hours" scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis population is the group of subjects who were randomized and received at least 1 dose of double-blind study drug'}, {'type': 'SECONDARY', 'title': 'Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind BTDS 10 or 20', 'description': 'Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo patches to match the BTDS patches applied for 7-day wear'}], 'classes': [{'categories': [{'measurements': [{'value': '0.701', 'spread': '0.8139', 'groupId': 'OG000'}, {'value': '0.740', 'spread': '0.8566', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7098', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.037', 'ciLowerLimit': '-0.233', 'ciUpperLimit': '0.159', 'pValueComment': 'To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.', 'groupDescription': "Categorical analysis P value is based on a Fisher's exact test. Mean daily number of tablets for subjects who took \\<=1 dose of supplemental analgesia", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'with treatment as a factor and screening and pre-randomization mean pain as covariates.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen).', 'unitOfMeasure': 'tablets', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the full analysis population who took at least 1 dose of supplemental analgesic medication.'}, {'type': 'SECONDARY', 'title': 'Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind BTDS 10 or 20', 'description': 'Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo patches to match the BTDS patches applied for 7-day wear'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '49.51', 'spread': '24.790', 'groupId': 'OG000'}, {'value': '51.23', 'spread': '25.945', 'groupId': 'OG001'}]}]}, {'title': 'Prerandomization', 'categories': [{'measurements': [{'value': '23.23', 'spread': '19.583', 'groupId': 'OG000'}, {'value': '26.04', 'spread': '20.822', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '27.22', 'spread': '23.086', 'groupId': 'OG000'}, {'value': '35.08', 'spread': '25.565', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '27.46', 'spread': '23.795', 'groupId': 'OG000'}, {'value': '34.78', 'spread': '24.715', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '29.60', 'spread': '25.177', 'groupId': 'OG000'}, {'value': '33.63', 'spread': '25.606', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.46', 'ciLowerLimit': '-7.44', 'ciUpperLimit': '-1.48', 'pValueComment': 'To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.', 'groupDescription': 'Weeks 4, 8, 12 analysis The sleep disturbance subscale was analyzed using the mixed effect linear model with fixed effects for treatment (BTDS or placebo) and time (weeks 1, 2, 4, 8, 12) as categorical, screening mean and prerandomization mean value as covariates, and subject as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, and 12 of the double-bind phase', 'description': 'The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population (N = 570) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double-blind BTDS 10 or 20', 'description': 'Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear'}, {'id': 'FG001', 'title': 'Double-blind Placebo', 'description': 'Placebo patches to match the BTDS patches applied for 7-day wear'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '282'}, {'groupId': 'FG001', 'numSubjects': '285'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '191'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '94'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': '27-Sep-2007 (first patient first visit) to 28-Apr-2009 (last patient last visit) at 83 medical/research sites in US', 'preAssignmentDetails': 'Open-label run-in period designed to select those subjects who both tolerated and responded to treatment with BTDS 10 or BTDS 20 (an enriched design). N = 1151 entered the run-in period, and N = 571 completed. One subject was not dosed, therefore N = 570 randomized. N = 3 subjects did not have safety data, therefore N = 567 had double-blind data.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'BG000'}, {'value': '285', 'groupId': 'BG001'}, {'value': '567', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Double-blind BTDS 10 or 20', 'description': 'Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear'}, {'id': 'BG001', 'title': 'Double-blind Placebo', 'description': 'Placebo patches to match the BTDS patches applied for 7-day wear'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'spread': '9.75', 'groupId': 'BG000'}, {'value': '59.1', 'spread': '9.77', 'groupId': 'BG001'}, {'value': '59.1', 'spread': '9.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}], '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': 567}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-05', 'studyFirstSubmitDate': '2007-09-17', 'resultsFirstSubmitDate': '2010-07-28', 'studyFirstSubmitQcDate': '2007-09-17', 'lastUpdatePostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-24', 'studyFirstPostDateStruct': {'date': '2007-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase.', 'timeFrame': '24 hours (week 12)', 'description': '"Average pain over the last 24 hours" scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily.'}], 'secondaryOutcomes': [{'measure': 'Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.', 'timeFrame': '10 weeks', 'description': 'Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen).'}, {'measure': 'Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.', 'timeFrame': 'Weeks 4, 8, and 12 of the double-bind phase', 'description': 'The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic pain,', 'OA of the knee,', 'opioid,', 'transdermal'], 'conditions': ['Chronic Pain', 'Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.', 'detailedDescription': 'Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition,\n* clinical diagnosis of OA of the knee 1 year or longer,\n* subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of \\< 5 mg oxycodone (or equivalent) per day,\n* subjects whose OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy.\n\nExclusion Criteria:\n\n* subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study,\n* subjects who are allergic to buprenorphine or who have a history of allergies to other opioids,\n* subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.\n\nOther protocol-specific inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00531427', 'briefTitle': 'Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Purdue Pharma LP'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee', 'orgStudyIdInfo': {'id': 'BUP3025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Buprenorphine transdermal system 10 and 20 applied for 7-day wear', 'interventionNames': ['Drug: Buprenorphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo transdermal system to match BTDS patches, applied for 7-day wear', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Buprenorphine', 'type': 'DRUG', 'description': 'transdermal system 10 and 20 applied for 7-day wear', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'transdermal system (placebo) applied for 7-day wear', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Coastal Clinical Research, Inc.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research, Phoenix Southeast', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center, Inc.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85029', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Lovelace Scientific Resources, Inc.', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 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