Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-12 @ 11:22 AM
Study NCT ID:
NCT05790902
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2023-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C095285', 'term': 'silodosin'}, {'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2023-03-17', 'studyFirstSubmitQcDate': '2023-03-17', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone clearance rate', 'timeFrame': 'upto 4 weeks', 'description': 'Stone clearance rate'}], 'secondaryOutcomes': [{'measure': 'Stone expulsion time', 'timeFrame': 'upto 4 weeks', 'description': 'Stone expulsion time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Silodosin, Tamsulosin, Medical Expulsive Therapy, Distal Ureteric Calculi']}, 'descriptionModule': {'briefSummary': 'to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi.', 'detailedDescription': 'to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi in our local setup to find out the optimal drug which promptly and quickly cures the disease thus enabling the person to return to routine activity with less adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic, unilateral, single, uncomplicated Distal Ureteric Calculi of \\<10 mm in size (on plain CT KUB)\n\nExclusion Criteria:\n\n* solitary kidney, bilateral ureteric stones, UTI, renal impairment, high-grade hydronephrosis (Grades 3 and 4), any history of previous endoscopic or surgical interventions, pregnancy, diabetes mellitus,'}, 'identificationModule': {'nctId': 'NCT05790902', 'briefTitle': 'COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI', 'organization': {'class': 'OTHER', 'fullName': 'Armed Forces Institute of Urology, Rawalpindi'}, 'officialTitle': 'COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI', 'orgStudyIdInfo': {'id': 'AFIU-2022-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Silodosin Group', 'description': 'The patients used Silodosin for ureteric calculi', 'interventionNames': ['Drug: Silodosin']}, {'type': 'EXPERIMENTAL', 'label': 'Tamsulosin Group', 'description': 'The patients used Tamsulosin for ureteric calculi', 'interventionNames': ['Drug: Tamsulosin']}], 'interventions': [{'name': 'Silodosin', 'type': 'DRUG', 'description': 'The patients used Silodosin for Medical expulsive therapy of ureteric calculi', 'armGroupLabels': ['Silodosin Group']}, {'name': 'Tamsulosin', 'type': 'DRUG', 'description': 'The patients used Tamsulosin for Medical expulsive therapy of ureteric calculi', 'armGroupLabels': ['Tamsulosin Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'AFIU Rawalpindi', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armed Forces Institute of Urology, Rawalpindi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR ABDUL JABBAR ARIF', 'investigatorFullName': 'AJ Arif', 'investigatorAffiliation': 'Armed Forces Institute of Urology, Rawalpindi'}}}}