Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-05 @ 3:31 AM
Study NCT ID:
NCT00600405
Status:
COMPLETED
Last Update Posted:
2008-01-25
First Post:
2008-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D014514', 'term': 'Ureteral Calculi'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D053039', 'term': 'Ureterolithiasis'}, {'id': 'D014515', 'term': 'Ureteral Diseases'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077409', 'term': 'Tamsulosin'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D010098', 'term': 'Oxycodone'}], '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'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-14', 'studyFirstSubmitDate': '2008-01-14', 'studyFirstSubmitQcDate': '2008-01-14', 'lastUpdatePostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of spontaneous ureteral stone expulsion', 'timeFrame': '48, 120, 336 hours'}], 'secondaryOutcomes': [{'measure': 'Time to spontaneous ureteral stone expulsion.', 'timeFrame': '48, 120, 336 hours'}, {'measure': 'Self-reported NRS-11 pain scores.', 'timeFrame': '48, 120, 336 hours'}, {'measure': 'Number of colicky pain episodes.', 'timeFrame': '48, 120, 336 hours'}, {'measure': 'Number of days missed work or usual functional ability.', 'timeFrame': '48, 120, 336 hours'}, {'measure': 'Number of return ED visits or unscheduled PCP visits for continued pain.', 'timeFrame': '48, 120, 336 hours'}, {'measure': 'Amount of narcotic pain medication used.', 'timeFrame': '48, 120, 336 hours'}, {'measure': 'Adverse medication-related events.', 'timeFrame': '48, 120, 336 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nephrolithiasis', 'Ureteral Calculi'], 'conditions': ['Nephrolithiasis', 'Ureteral Calculi']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of the α-adrenergic antagonist tamsulosin in the treatment of adult emergency department (ED) patients with ureteral colic secondary to lower ureteral calculus. We hypothesize that there will be no difference in outcomes for subjects treated with and without tamsulosin.', 'detailedDescription': 'This prospective, randomized controlled trial seeks to compare outcomes for adult emergency department patients with lower ureteral calculus. Subjects will be randomized to receive treatment with ibuprofen and oxycodone alone (standard therapy) or standard therapy plus tamsulosin 0.4mg orally once daily for ten days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older;\n* able to read, write, and speak English;\n* able to use the NRS pain scale; and\n* computed tomography diagnosed single lower ureteral calculus\n\nExclusion Criteria:\n\n* allergy or sensitivity to the study drug (tamsulosin hydrochloride \\[Flomax\\]);\n* sulfa/sulfonamide allergy;\n* inability to provide informed consent;\n* lithiasis of the ureteral intramural tract;\n* acute or chronic renal failure;\n* fever;\n* presence of multiple ureteral stones;\n* peptic ulcer disease;\n* liver failure;\n* concomitant treatment with alpha-lytic drugs, calcium antagonists, nitrates, or vardenafil (Levitra);\n* pregnancy;\n* breastfeeding; or\n* a history of urinary surgery or endoscopic treatment.'}, 'identificationModule': {'nctId': 'NCT00600405', 'briefTitle': 'The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients', 'organization': {'class': 'OTHER', 'fullName': 'MaineHealth'}, 'officialTitle': 'The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients', 'orgStudyIdInfo': {'id': '2958'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I', 'description': 'Subjects randomized to the experimental group receive ibuprofen, oxycodone, and tamsulosin 0.4 mg orally daily for ten days.', 'interventionNames': ['Drug: tamsulosin']}, {'type': 'OTHER', 'label': 'II', 'description': 'Standard therapy arm: subjects randomized to standard therapy receive ibuprofen and oxycodone alone.', 'interventionNames': ['Drug: Standard therapy with ibuprofen and oxycodone.']}], 'interventions': [{'name': 'tamsulosin', 'type': 'DRUG', 'otherNames': ['Flomax'], 'description': 'Tamsulosin 0.4 mg orally daily for ten days.', 'armGroupLabels': ['I']}, {'name': 'Standard therapy with ibuprofen and oxycodone.', 'type': 'DRUG', 'description': 'Oxycodone: 5mg, one to two tablets every four to six hours as needed for pain. Ibuprofen: 800 mg, one three times a day with food as needed for pain.', 'armGroupLabels': ['II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}], 'overallOfficials': [{'name': 'Andrew D Perron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MaineHealth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MaineHealth', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maine Medical Center Mentored Research Committee', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Andrew Perron, MD', 'oldOrganization': 'Maine Medical Center'}}}}