Ignite Creation Date:
2025-12-25 @ 3:41 AM
Ignite Modification Date:
2025-12-26 @ 2:27 AM
Study NCT ID:
NCT00454402
Status:
TERMINATED
Last Update Posted:
2007-09-24
First Post:
2007-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ALF-STONE: Alfuzosin in Uretheric Stones
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C047638', 'term': 'alfuzosin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'whyStopped': 'Discontinued due to incomplete recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-21', 'studyFirstSubmitDate': '2007-03-29', 'studyFirstSubmitQcDate': '2007-03-29', 'lastUpdatePostDateStruct': {'date': '2007-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: General clinical safety by collection of spontaneously reported adverse events', 'timeFrame': 'at each visit'}, {'measure': 'Efficacy: Percentage of patients without imagiologic evidence of any stone', 'timeFrame': '72h to 96 hours after ESWL'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients without imagiologic evidence of any stone', 'timeFrame': '24 hours after ESWL'}, {'measure': 'Percentage of patients with clinical evidence of stones clearance', 'timeFrame': '72h to 96 hours after ESWL'}, {'measure': 'Time for stone clearance (clinical evaluation)'}, {'measure': 'Numeric Rating Scale scores', 'timeFrame': 'at 24h, (48h, if applicable), 72-96h and 7 days'}, {'measure': 'Need for rescue analgesic medication.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours.\n\nThis study will also specifically focus on the evaluation of time of stone clearance and of pain reduction (Numeric Rating Scale).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients with imagiologic evidence of uretheric stones\n\nExclusion criteria:\n\n* Women pregnant or breast feeding\n* Patients with renal impairment (creatinine \\> 2mg/dl)\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00454402', 'briefTitle': 'ALF-STONE: Alfuzosin in Uretheric Stones', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Alfuzosin in Uretheric Stones', 'orgStudyIdInfo': {'id': 'L_9795'}, 'secondaryIdInfos': [{'id': 'EudraCT # : 2005-005481-36'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Alfuzosin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'overallOfficials': [{'name': 'Carlos Santos, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}