Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-01 @ 1:21 AM
Study NCT ID:
NCT01332435
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2011-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'This was a retrospective database study, and adverse event/serious adverse event information was not captured in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'IHCIS; Early 5ARI Initiation', 'description': 'Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. 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Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI \\[dutasteride and finasteride\\]) within 30 days of an alpha-blocker (AB \\[doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin\\]).'}, {'id': 'BG001', 'title': 'IHCIS; Late 5ARI Initiation', 'description': 'Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \\> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).'}, {'id': 'BG002', 'title': 'PharMetrics; Early 5ARI Initiation', 'description': 'Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).'}, {'id': 'BG003', 'title': 'PharMetrics; Late 5ARI Initiation', 'description': 'Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \\> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>=50 years old', 'categories': [{'measurements': [{'value': '1572', 'groupId': 'BG000'}, {'value': '1064', 'groupId': 'BG001'}, {'value': '2604', 'groupId': 'BG002'}, {'value': '1656', 'groupId': 'BG003'}, {'value': '6896', 'groupId': 'BG004'}]}]}, {'title': '<50 years old', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1572', 'groupId': 'BG000'}, {'value': '1064', 'groupId': 'BG001'}, {'value': '2604', 'groupId': 'BG002'}, {'value': '1656', 'groupId': 'BG003'}, {'value': '6896', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6896}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2011-04-07', 'resultsFirstSubmitDate': '2011-04-14', 'studyFirstSubmitQcDate': '2011-04-07', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-06-23', 'studyFirstPostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinical Progression', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.'}, {'measure': 'Number of Participants With Acute Urinary Retention', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.'}, {'measure': 'Number of Participants Who Needed Prostate-Related Surgery', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.'}], 'secondaryOutcomes': [{'measure': 'Total BPH-related Costs', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).'}, {'measure': 'BPH-related Medical Costs', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).'}, {'measure': 'BPH-related Pharmacy Costs', 'timeFrame': 'Day 1 of a 1-day study', 'description': 'Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).'}]}, 'conditionsModule': {'keywords': ['Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, early, costs'], 'conditions': ['Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study aims to identify eligible patient data between July 1, 2000, and December 31, 2006, and allows for patient data to be followed for 6 months prior to and up to 1 year following index prescription date.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients aged 50 years or older\n* a medical claim of EP\n* a prescription claim for a 5ARI and AB (provided both are within 180 days of index date)\n* continuously eligible for 6 months prior to and at least 12 months after index prescription date.\n\nExclusion Criteria:\n\n* diagnosis of prostate or bladder cancer\n* any prostate-related surgical procedure within 5 months of index date\n* prescription claim for finasteride indicative of male pattern baldness\n* 5ARI therapy initiated prior to initiating AB therapy'}, 'identificationModule': {'nctId': 'NCT01332435', 'briefTitle': 'Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use', 'orgStudyIdInfo': {'id': '113984'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early 5ARI Initiation', 'description': 'Patients with EP receiving combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)', 'interventionNames': ['Drug: 5ARI + AB']}, {'label': 'Late 5ARI Initiation', 'description': 'Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (more than 30 days but less than 6 months after initiation of AB)', 'interventionNames': ['Drug: 5ARI + AB']}], 'interventions': [{'name': '5ARI + AB', 'type': 'DRUG', 'description': '5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin', 'armGroupLabels': ['Early 5ARI Initiation', 'Late 5ARI Initiation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}