Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-29 @ 9:41 AM
Study NCT ID:
NCT00224120
Status:
COMPLETED
Last Update Posted:
2009-12-15
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
Sponsor:
Organization:
Raw JSON
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daily with food', 'otherNumAtRisk': 233, 'otherNumAffected': 99, 'seriousNumAtRisk': 233, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo capsule once daily with food', 'otherNumAtRisk': 229, 'otherNumAffected': 15, 'seriousNumAtRisk': 229, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Retrograde ejaculation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 64, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostatic specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Atrioventricular block third degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Enterocolitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lesion excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silodosin', 'description': 'Silodosin 8 mg once daily with food'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo capsule once daily with food'}], 'classes': [{'title': 'Baseline IPSS', 'categories': [{'measurements': [{'value': '21.2', 'spread': '4.88', 'groupId': 'OG000'}, {'value': '21.2', 'spread': '4.92', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in IPSS at Week 12', 'categories': [{'measurements': [{'value': '-6.3', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '5.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).', 'anticipatedPostingDate': '2009-09'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silodosin', 'description': 'Silodosin 8 mg once daily with food'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo capsule once daily with food'}], 'classes': [{'title': 'Baseline Qmax', 'categories': [{'measurements': [{'value': '8.4', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '2.67', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in Qmax at Week 12', 'categories': [{'measurements': [{'value': '2.9', 'spread': '4.53', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '4.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2009-09'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Silodosin', 'description': 'Silodosin 8 mg once daily with food'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo capsule once daily with food'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}, {'groupId': 'FG001', 'numSubjects': '229'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '205'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '462', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Silodosin', 'description': 'Silodosin 8 mg once daily with food'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo capsule once daily with food'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'spread': '8.21', 'groupId': 'BG000'}, {'value': '65.3', 'spread': '8.23', 'groupId': 'BG001'}, {'value': '65.1', 'spread': '8.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '462', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '462', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 462}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-11', 'studyFirstSubmitDate': '2005-09-14', 'resultsFirstSubmitDate': '2009-09-08', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-30', 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Benign prostatic hyperplasia, alpha blocker'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '19371887', 'type': 'BACKGROUND', 'citation': 'Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009 Jun;181(6):2634-40. doi: 10.1016/j.juro.2009.02.034. Epub 2009 Apr 16.'}, {'pmid': '23234617', 'type': 'DERIVED', 'citation': 'Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha(1A)-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2013 Jan;189(1 Suppl):S122-8. doi: 10.1016/j.juro.2012.11.020.'}, {'pmid': '21135869', 'type': 'DERIVED', 'citation': 'Roehrborn CG, Kaplan SA, Lepor H, Volinn W. Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH. Prostate Cancer Prostatic Dis. 2011 Jun;14(2):143-8. doi: 10.1038/pcan.2010.46. Epub 2010 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.', 'detailedDescription': 'This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.'}, '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, with symptoms of moderate to severe BPH.\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': 'NCT00224120', 'briefTitle': 'A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Watson Pharmaceuticals'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': 'SI04010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Silodosin', 'description': 'Silodosin 8 mg/Day with food', 'interventionNames': ['Drug: Silodosin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo capsule once daily with food', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Silodosin', 'type': 'DRUG', 'otherNames': ['Rapaflo'], 'description': '8 mg daily for 12 weeks', 'armGroupLabels': ['Silodosin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'One capsule daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Laguna Woods', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.6103, 'lon': -117.72533}}, {'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'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': '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': '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': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Melrose Park', 'state': 'Illinois', 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'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'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': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'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}}], 'overallOfficials': [{'name': 'Lawrence Hill, PharmD, 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.'}}}}