Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00224133
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C095285', 'term': 'silodosin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gary.hoel@watson.com', 'phone': '801-588-6641', 'title': 'Gary Hoel, RPh, PhD, Executive Director of Clinical Research', 'organization': 'Watson Laboratories, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '9 months', 'description': 'No subject experienced a serious adverse event that was related to treatment.', 'eventGroups': [{'id': 'EG000', 'title': '8 mg Silodosin Per Day With Food', 'otherNumAtRisk': 661, 'otherNumAffected': 138, 'seriousNumAtRisk': 661, 'seriousNumAffected': 29}], 'otherEvents': [{'term': 'Retrograde ejaculation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 139, 'numAffected': 138}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arrythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nerve root lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal laminectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 661, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '661', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '8 mg Silodosin Per Day With Food'}], 'classes': [{'title': 'Patients with at least 1 adverse event', 'categories': [{'measurements': [{'value': '431', 'groupId': 'OG000'}]}]}, {'title': 'Patients with drug related adverse event', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}]}]}, {'title': 'Patients with a serious adverse events', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Patients with a drug related serious adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Patients discontinued due to an adverse event', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Discontinued for drug related adverse event', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'description': 'All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was analyzed. This population is defined as all enrolled patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'International Prostate Symptom Score (IPSS)', 'paramType': 'MEAN', 'timeFrame': '9 months', 'description': 'The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2010-03'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '8 mg Silodosin Per Day With Food'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '661'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '435'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '93'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '661', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '8 mg Silodosin Per Day With Food'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '356', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '305', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'spread': '7.79', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '661', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '661', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 661}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-06', 'studyFirstSubmitDate': '2005-09-14', 'resultsFirstSubmitDate': '2009-12-23', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-06', 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '9 months', 'description': 'All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.'}], 'secondaryOutcomes': [{'measure': 'International Prostate Symptom Score (IPSS)', 'timeFrame': '9 months', 'description': 'The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['benign prostatic hyperplasia, alpha blocker'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '19815265', 'type': 'RESULT', 'citation': 'Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study. Urology. 2009 Dec;74(6):1318-22. doi: 10.1016/j.urology.2009.06.072. Epub 2009 Oct 7.'}], 'seeAlsoLinks': [{'url': 'http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails', 'label': 'FDA approval summary and product label'}]}, 'descriptionModule': {'briefSummary': 'A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.', 'detailedDescription': 'This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance.\n\nAll subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010.\n\nExclusion Criteria:\n\n* Medical conditions that would confound the efficacy evaluation.\n* Medical conditions in which it would be unsafe to use an alpha-blocker.\n* The use of concomitant drugs that would confound the efficacy evaluation.\n* The use of concomitant drugs that would be unsafe with this alpha-blocker.'}, 'identificationModule': {'nctId': 'NCT00224133', 'briefTitle': 'The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months', 'organization': {'class': 'INDUSTRY', 'fullName': 'Watson Pharmaceuticals'}, 'officialTitle': 'A Multi-Center, Open-Label Evaluation of the Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': 'SI04011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Silodosin', 'description': 'Silodosin 8 mg per day with food', 'interventionNames': ['Drug: Silodosin']}], 'interventions': [{'name': 'Silodosin', 'type': 'DRUG', 'otherNames': ['Rapaflo'], 'description': '8 mg daily', 'armGroupLabels': ['Silodosin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'city': 'Culver City', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Irvine', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Laguna Woods', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.6103, 'lon': -117.72533}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Melrose Park', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.90059, 'lon': -87.85673}}, {'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'city': 'Greenbelt', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.00455, 'lon': -76.87553}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Albany', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'Bay Shore', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.7251, 'lon': -73.24539}}, {'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'city': 'Kingston', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 41.92704, 'lon': -73.99736}}, {'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Concord', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.40888, 'lon': -80.58158}}, {'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Bethany', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.51867, 'lon': -97.63226}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Lakewood', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.17176, 'lon': -122.51846}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Lawrence Hill, Pharm D, RPh', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Watson Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Watson Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Gary Hoel, RPh, PhD, Executive Director of Clinical Research', 'oldOrganization': 'Watson Laboratories, Inc.'}}}}