Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT00423605
Status:
COMPLETED
Last Update Posted:
2012-03-30
First Post:
2007-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012978', 'term': 'Sodium Oxybate'}], 'ancestors': [{'id': 'D006885', 'term': 'Hydroxybutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '650-496-3777', 'title': 'Grace Wang, MD, Director Clinical Development & Medical Monitor', 'organization': 'Jazz Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '38 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Xyrem 4.5 g to 9.0 g', 'description': 'Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses', 'otherNumAtRisk': 560, 'otherNumAffected': 498, 'seriousNumAtRisk': 560, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 12}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 112}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 50}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 106}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 72}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 44}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 38}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 24}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'seriousEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gastrointestinal Hypomotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cholecystitis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Clostridium Difficile Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Staphylococcal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Limb Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cervical Spinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Breast Cancer in Situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Mental Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 560, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '560', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Xyrem 4.5 g to 9.0 g', 'description': 'Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses'}], 'classes': [{'categories': [{'measurements': [{'value': '498', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment Period (38 weeks)', 'description': 'Number of subjects reporting adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Xyrem 4.5 g to 9.0 g', 'description': 'Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '560'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '319'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '129'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Not one of the pre-specified options', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '560', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Xyrem 4.5 g to 9.0 g', 'description': 'Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'spread': '10.84', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 - 39 years', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}]}]}, {'title': '40 - 49 years', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}]}]}, {'title': '50 - 64 years', 'categories': [{'measurements': [{'value': '212', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '510', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '512', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '465', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 560}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-28', 'studyFirstSubmitDate': '2007-01-16', 'resultsFirstSubmitDate': '2011-09-12', 'studyFirstSubmitQcDate': '2007-01-16', 'lastUpdatePostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-12', 'studyFirstPostDateStruct': {'date': '2007-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Reporting Adverse Events', 'timeFrame': 'Treatment Period (38 weeks)', 'description': 'Number of subjects reporting adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FMS', 'Fibro', 'Pain', 'Body Pain', 'Tenderness', 'Joint pain', 'Stiffness', 'Muscular Pain'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Spaeth M, Russell IJ, Perrot S, Alvarez-Horine S, Guinta D, Wang YG, Bennett R. Durability of Response in a 38-Week Open-Label Study of Sodium Oxybate in Patients With Fibromyalgia [ACR/ARHP abstract 2356]. Arthritis Rheum. 2010;62(suppl 10):97.'}, {'pmid': '24286114', 'type': 'DERIVED', 'citation': 'Spaeth M, Alegre C, Perrot S, Wang Y, Guinta DR, Alvarez-Horine S, Russell I; Sodium Oxybate Fibromyalgia Study Group. Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia. Arthritis Res Ther. 2013 Nov 11;15(6):R185. doi: 10.1186/ar4375.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.', 'detailedDescription': 'The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137).\n* Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months.\n\nExclusion Criteria:\n\n* Subject terminated early from either study 06-009 or 06-008.\n* Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008.\n* Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.'}, 'identificationModule': {'nctId': 'NCT00423605', 'briefTitle': 'Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': 'A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.', 'orgStudyIdInfo': {'id': '06-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Xyrem®']}], 'interventions': [{'name': 'Xyrem®', 'type': 'DRUG', 'description': 'flexible dosing', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group, LLC', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'city': 'Auburn', 'state': 'Alabama', 'country': 'United States', 'facility': 'Suncoast Internal Medicine Consultants', 'geoPoint': {'lat': 32.60986, 'lon': -85.48078}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Research', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'city': 'Fair Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Med Investigations Inc.', 'geoPoint': {'lat': 38.64463, 'lon': -121.27217}}, {'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Nerve Pro Research', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '93449', 'city': 'Pismo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Arroyo Medical Group, Inc.', 'geoPoint': {'lat': 35.14275, 'lon': -120.64128}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'AppleMed Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33317', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Sunrise Medical Research', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Group of St. Petersburg, Inc', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa Medical Group, P.A.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Arthiritis and Rheumatism', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'city': 'Zephyhills', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Medical Clinic, P.A.'}, {'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Drug Studies America', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'city': "Coeur d'Alene", 'state': 'Idaho', 'country': 'United States', 'facility': "Coeur d' Alene Arthritis Clinic", 'geoPoint': {'lat': 47.67768, 'lon': -116.78047}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Fibromyalgia Treatment Centers of America', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60031', 'city': 'Gurnee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Deerpath Physcians Group', 'geoPoint': {'lat': 42.3703, 'lon': -87.90202}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Balanced Health Research Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '42101', 'city': 'Bowling Green', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Graves - Gilbert Clinic', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'city': 'Elizabethtown', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Center for Arthiritis & Osteoporosis', 'geoPoint': {'lat': 37.69395, 'lon': -85.85913}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Kentucky Research Associates, Inc.', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '42431', 'city': 'Madisonville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Commonwealth Biomedical Research, LLC', 'geoPoint': {'lat': 37.3281, 'lon': -87.49889}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana Sleep Foundation', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Capital Clinical Rsearch Asociates', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '01103', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'FutureCare Studies', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '01610', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Clinical Pharmacology Study Group', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'city': 'Benzonia', 'state': 'Michigan', 'country': 'United States', 'facility': 'Professional Clinical Research, Inc. at Crystal Lake Health Center', 'geoPoint': {'lat': 44.62139, 'lon': -86.09926}}, {'city': 'Cadillac', 'state': 'Michigan', 'country': 'United States', 'facility': 'Professional Clinical Research', 'geoPoint': {'lat': 44.25195, 'lon': -85.40116}}, {'zip': '49643', 'city': 'Interlocken', 'state': 'Michigan', 'country': 'United States', 'facility': 'Professional Clinical Research at Crystal Lake Health Center'}, {'zip': '48917', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'PCM Medical Services', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinvest', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '08002', 'city': 'Cherry Hill', 'state': 'New Jersey', 'country': 'United States', 'facility': 'School of Osteopathic Medicine', 'geoPoint': {'lat': 39.93484, 'lon': -75.03073}}, {'zip': '08817', 'city': 'Edison', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Anderson & Collins Clinical Research, Inc.', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'zip': '12205', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Upstate Clinical Research, LLC', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'AAIR Research Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Valley Stream', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.66427, 'lon': -73.70846}}, {'city': 'Boone', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Appalachian Regional Medical Associates', 'geoPoint': {'lat': 36.21679, 'lon': -81.67455}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Bone and Joint', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27103', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates, LLC', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Center for Clinical Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hill Top Physicians Inc./Hightop Medical Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44260', 'city': 'Mogadore', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 41.04645, 'lon': -81.39789}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Tulsa Clinical Research, LLC', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'PRO Research', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'School of Nursing', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15009', 'city': 'Beaver', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Tri State Medical Group, Inc.', 'geoPoint': {'lat': 40.69534, 'lon': -80.30478}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '17055', 'city': 'Mechanicsburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Central Pennsylvania Clinical Research', 'geoPoint': {'lat': 40.21426, 'lon': -77.00859}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Omega Medical Research', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Low Country Research Country', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Southern Orthopaedic Sports Medicine', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Radiant Research, Greer', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '37909', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Rheumatology Consultants, PLLC', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Walter F. Chase, MD PA', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'R/D Clinical Research, Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78205', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sun Research Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Radiant Research San Antonio Northeast', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84102', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Fatigue Consultation Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'Evergreen Hospital Medical Center', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'zip': '98055', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Pacific Rheumatology Associates, Inc.', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '25304', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Charleston Internal Medicine', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}, {'city': 'Amiens', 'country': 'France', 'facility': 'Rhumatologie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Échirolles', 'country': 'France', 'facility': 'CHU de Grenoble-Hopital Sud', 'geoPoint': {'lat': 45.14603, 'lon': 5.71441}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hopital Claude Huriez Service de medecine interne', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Centre Catherine de Sienne unite d evaluation et de traitement de la douleur', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Hotel Dieu service de medicine interne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Hopital de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Böblingen', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis fur anasthesie und spezielle Schmerztherapie', 'geoPoint': {'lat': 48.68212, 'lon': 9.01171}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Intensivmedizin der Uniklinik Koln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Praxis Dr. Wiedeking', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Gräfelfing', 'country': 'Germany', 'facility': 'Praxis fur Innere Medizin und Rheumatologie', 'geoPoint': {'lat': 48.11878, 'lon': 11.42939}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Schmerzzentrum', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'Praxisklinik Dr. Weiss', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Schwalmtal', 'country': 'Germany', 'facility': 'Praxis Dr. Sohn', 'geoPoint': {'lat': 51.21667, 'lon': 6.26667}}, {'city': 'Pisa', 'country': 'Italy', 'facility': 'Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Santa Creu i Snt Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Instituto Ferran de Reumatologia', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Guadalajara', 'country': 'Spain', 'facility': 'Hospital Universitario de Guadalajara', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Civil de Malaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Oviedo', 'country': 'Spain', 'facility': 'Hospital Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Bolton', 'country': 'United Kingdom', 'facility': 'Lever Chambers Centre for Health', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}