Viewing Study NCT00316732


Ignite Creation Date: 2025-12-24 @ 9:25 PM
Ignite Modification Date: 2025-12-25 @ 7:11 PM
Study NCT ID: NCT00316732
Status: COMPLETED
Last Update Posted: 2017-10-16
First Post: 2006-04-20
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS
Sponsor:
Organization:

Raw JSON

{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2006-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-13', 'studyFirstSubmitDate': '2006-04-20', 'studyFirstSubmitQcDate': '2006-04-20', 'lastUpdatePostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12-19', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Avodart', 'IPSS', 'BPH', 'dutasteride', 'EQ-5D', 'Observational'], 'conditions': ['Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'This study was designed to assess the effectiveness of dutasteride in the actual clinical practice of prostate assessment clinics in the UK in accordance with best practice over a 12-month period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who not have received any pharmacological treatment or surgical interventions for BPH (Benign Prostatic Hyperplasia).\n* Patients should be prescribed dutasteride in compliance with the UK SmPC and BAUS guidelines on the treatment of BPH.\n* Patients must only enter the study after the decision to prescribe dutasteride has been undertaken.\n\nExclusion criteria: None specified'}, 'identificationModule': {'nctId': 'NCT00316732', 'briefTitle': 'Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Observational Sutdy to Assess the Effectiveness of Avodart in Subjects With Benign Prostatic Hyperplasia in Day to Day Clinical Practice', 'orgStudyIdInfo': {'id': '103500'}}, 'armsInterventionsModule': {'interventions': [{'name': 'IPSS Questionnaire', 'type': 'PROCEDURE'}, {'name': 'EQ-5D Questionnaire', 'type': 'PROCEDURE', 'otherNames': ['IPSS Questionnaire']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX2 5DW', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, 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