Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT00443820
Status:
COMPLETED
Last Update Posted:
2011-04-19
First Post:
2007-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014009', 'term': 'Onychomycosis'}, {'id': 'D005533', 'term': 'Foot Dermatoses'}], 'ancestors': [{'id': 'D014005', 'term': 'Tinea'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077291', 'term': 'Terbinafine'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'description': 'Safety population consisting of all participants who had at least one dose of study drug and had at least one post-baseline safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Terbinafine 24 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks', 'otherNumAtRisk': 131, 'otherNumAffected': 37, 'seriousNumAtRisk': 131, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Vehicle 24 Weeks', 'description': 'Vehicle (placebo) for 24 weeks', 'otherNumAtRisk': 129, 'otherNumAffected': 38, 'seriousNumAtRisk': 129, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Terbinafine 48 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks', 'otherNumAtRisk': 134, 'otherNumAffected': 54, 'seriousNumAtRisk': 134, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Vehicle 48 Weeks', 'description': 'Vehicle (placebo) for 48 weeks', 'otherNumAtRisk': 126, 'otherNumAffected': 52, 'seriousNumAtRisk': 126, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Near drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Micturition disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Terbinafine 24 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks'}, {'id': 'OG001', 'title': 'Vehicle 24 Weeks', 'description': 'Vehicle (placebo) for 24 weeks'}, {'id': 'OG002', 'title': 'Terbinafine 48 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks'}, {'id': 'OG003', 'title': 'Vehicle 48 Weeks', 'description': 'Vehicle (placebo) for 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '-1.82', 'upperLimit': '3.29'}, {'value': '0.77', 'groupId': 'OG001', 'lowerLimit': '-1.82', 'upperLimit': '3.29'}, {'value': '2.96', 'groupId': 'OG002', 'lowerLimit': '0.10', 'upperLimit': '5.82'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.10', 'upperLimit': '5.82'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population, Last observation carried forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Terbinafine 24 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks'}, {'id': 'OG001', 'title': 'Vehicle 24 Weeks', 'description': 'Vehicle (placebo) for 24 weeks'}, {'id': 'OG002', 'title': 'Terbinafine 48 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks'}, {'id': 'OG003', 'title': 'Vehicle 48 Weeks', 'description': 'Vehicle (placebo) for 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '15.04', 'groupId': 'OG000', 'lowerLimit': '1.54', 'upperLimit': '16.23'}, {'value': '6.15', 'groupId': 'OG001', 'lowerLimit': '1.54', 'upperLimit': '16.23'}, {'value': '22.22', 'groupId': 'OG002', 'lowerLimit': '6.00', 'upperLimit': '22.82'}, {'value': '7.81', 'groupId': 'OG003', 'lowerLimit': '6.00', 'upperLimit': '22.82'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population, Last observation carried forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Terbinafine 24 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks'}, {'id': 'OG001', 'title': 'Vehicle 24 Weeks', 'description': 'Vehicle (placebo) for 24 weeks'}, {'id': 'OG002', 'title': 'Terbinafine 48 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks'}, {'id': 'OG003', 'title': 'Vehicle 48 Weeks', 'description': 'Vehicle (placebo) for 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.01', 'groupId': 'OG000'}, {'value': '0.77', 'groupId': 'OG001'}, {'value': '5.93', 'groupId': 'OG002'}, {'value': '0.78', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and \\<= 10% residual involvement of the target toenail.\n\nClinical effectiveness was a composite binary variable defined as "Yes" if:\n\n* If mycological cure (negative KOH and negative culture for dermatophytes) and\n* = 10% residual involvement of the target toenail "No" if otherwise', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population, Last observation carried forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability Assessed by the Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Terbinafine 24 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks'}, {'id': 'OG001', 'title': 'Vehicle 24 Weeks', 'description': 'Vehicle (placebo) for 24 weeks'}, {'id': 'OG002', 'title': 'Terbinafine 48 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks'}, {'id': 'OG003', 'title': 'Vehicle 48 Weeks', 'description': 'Vehicle (placebo) for 48 weeks'}], 'classes': [{'title': 'At least 1 AE', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}]}, {'title': 'At least 1 SAE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Study drug discontinued due to an AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE and death. Additional details can be found in the Adverse Event Section.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population', 'anticipatedPostingDate': '2011-01'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Terbinafine 24 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks'}, {'id': 'FG001', 'title': 'Vehicle 24 Weeks', 'description': 'Vehicle (placebo) for 24 weeks'}, {'id': 'FG002', 'title': 'Terbinafine 48 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks'}, {'id': 'FG003', 'title': 'Vehicle 48 Weeks', 'description': 'Vehicle (placebo) for 48 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '135'}, {'groupId': 'FG003', 'numSubjects': '128'}]}, {'type': 'Safety Population', 'achievements': [{'comment': 'Participants who received study drug and had at least one post-baseline safety assessment.', 'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '129'}, {'groupId': 'FG002', 'numSubjects': '134'}, {'groupId': 'FG003', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'comment': "A participant from this gr. discont'ed due to renal failure, was counted as an AE and also as a SAE.", 'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '117'}, {'groupId': 'FG003', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This randomized, double -blind, vehicle -controlled, multicenter, parallel group study was designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine hydrogen chloride 10% topical solution (TTS10%) applied daily in patients with toenail onychomycosis. Started 07 DEC 2006 and ending 27 JUN 2008.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}, {'value': '526', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Terbinafine 24 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks'}, {'id': 'BG001', 'title': 'Vehicle 24 Weeks', 'description': 'Vehicle (placebo) for 24 weeks'}, {'id': 'BG002', 'title': 'Terbinafine 48 Weeks', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks'}, {'id': 'BG003', 'title': 'Vehicle 48 Weeks', 'description': 'Vehicle (placebo) for 48 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '388', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '149', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '377', 'groupId': 'BG004'}]}]}], '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': 526}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-22', 'studyFirstSubmitDate': '2007-03-02', 'resultsFirstSubmitDate': '2011-01-19', 'studyFirstSubmitQcDate': '2007-03-05', 'lastUpdatePostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-22', 'studyFirstPostDateStruct': {'date': '2007-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks', 'timeFrame': '52 weeks', 'description': 'Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.'}], 'secondaryOutcomes': [{'measure': 'Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks', 'timeFrame': '52 weeks', 'description': 'Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.'}, {'measure': 'Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks', 'timeFrame': '52 weeks', 'description': 'Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and \\<= 10% residual involvement of the target toenail.\n\nClinical effectiveness was a composite binary variable defined as "Yes" if:\n\n* If mycological cure (negative KOH and negative culture for dermatophytes) and\n* = 10% residual involvement of the target toenail "No" if otherwise'}, {'measure': 'Safety and Tolerability Assessed by the Number of Participants With Adverse Events', 'timeFrame': '52 weeks', 'description': 'Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE and death. Additional details can be found in the Adverse Event Section.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Toenail fungus', 'Onychomycosis', 'Nail fungus', 'Toenail fungal infection', 'Tinea unguium', 'Dermatophytes', 'Foot dermatoses'], 'conditions': ['Onychomycosis']}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and females 12 - 75 years of age\n* Fungal toenail infection of one or both of the large (great) toenails\n* The nail infection must be due to a dermatophyte, (mixed infections dermatophyte and non-dermatophyte\\] are not allowed)\n\nExclusion Criteria:\n\n* Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinafine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.\n* Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved\n* No administration of systemic antifungal medications within 6 months prior to screening visit\n* No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit\n* No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit\n* Known pregnancy or lactation at time of enrollment\n\nOther protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT00443820', 'briefTitle': 'Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Topical Terbinafine Hydrogen Chloride (HCl) Formulation for 24 or 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis', 'orgStudyIdInfo': {'id': 'CSFO327N2302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks', 'interventionNames': ['Drug: terbinafine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Vehicle (placebo) for 48 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks', 'interventionNames': ['Drug: terbinafine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Vehicle (placebo) for 24 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'terbinafine', 'type': 'DRUG', 'otherNames': ['Lamisil'], 'description': 'Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Vehicle (placebo) once daily for 48 weeks', 'armGroupLabels': ['2']}, {'name': 'terbinafine', 'type': 'DRUG', 'otherNames': ['Lamisil'], 'description': 'Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks', 'armGroupLabels': ['3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Vehicle (placebo) once daily for 24 weeks', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94945', 'city': 'Novato', 'state': 'California', 'country': 'United States', 'facility': 'Dr. Fred D. 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Dunne', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '30263', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dr. Mark Ling', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '60632', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Dr. Jesse Plasencia', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66215', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Dr. John Mallory', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'Dr. Jeffrey Conrow', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Dr.Michael Kaye', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '21214', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Dr. Max Weisfeld', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Dr. Linda Stein-Gold', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Dr. Anna Glaser', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Dr. Richard Scher', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dr. Joseph Jorrizo', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45230', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dr. Anne Lucky', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Dr. Rich Phoebe', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29681', 'city': 'Simpsonville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Dr. Patricia Westmorland', 'geoPoint': {'lat': 34.73706, 'lon': -82.25428}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Dr. David Horowitz', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75061', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'Dr. Jay Lifshen', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Dr. Richard Pollak', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23464', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Dr. Patrick Agnew', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'city': 'Various Cities', 'country': 'France', 'facility': 'Novartis Investigative Site'}, {'city': 'Investigative Site', 'country': 'Germany', 'facility': 'Novartis'}, {'city': 'Various Cities', 'country': 'Germany', 'facility': 'Novartis Investigative Site'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}