Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-03 @ 11:42 AM
Study NCT ID:
NCT00151567
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Tamsulosin in the Treatment of Ureteral Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053039', 'term': 'Ureterolithiasis'}, {'id': 'D014514', 'term': 'Ureteral Calculi'}], 'ancestors': [{'id': 'D014515', 'term': 'Ureteral 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': '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'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-03', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to stone elimination in days (censored criterion)', 'timeFrame': 'between day 1 and 42'}], 'secondaryOutcomes': [{'measure': 'Time to stone elimination in days in patients with spontaneous elimination (quantitative criterion)', 'timeFrame': 'between day 1 and 42'}, {'measure': 'Pain using Visual Analogue Scale', 'timeFrame': 'days 1, 2, 3'}, {'measure': 'Spontaneous stone elimination rate', 'timeFrame': 'days 1, 7, 14, 21, 28, 35, and 42'}, {'measure': 'Spontaneous stone elimination rate, according to stone size (2-3 mm, 4-5 mm, 6-7 mm)', 'timeFrame': 'days 1, 7, 14, 21, 28, 35, and 42'}, {'measure': 'Rate of need for surgery', 'timeFrame': 'Within 42 days'}, {'measure': 'Time to surgery in days in patients with surgical elimination', 'timeFrame': 'between day 1 and day 42'}, {'measure': 'Rate of pain recurrences', 'timeFrame': 'within 42 days'}, {'measure': 'Time to the first recurrence in days', 'timeFrame': 'between day 1 and day 42'}, {'measure': 'Rate of need for corticoids or morphine', 'timeFrame': 'Within 42 days'}, {'measure': 'Time to the first administration of corticoids or morphine in days', 'timeFrame': 'between day 1 and day 42'}, {'measure': 'Rate of adverse events', 'timeFrame': 'Within 42 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ureterolithiasis', 'Alpha1-blocker', 'Lower ureteral stone'], 'conditions': ['Ureterolithiasis', 'Ureteral Calculi']}, 'referencesModule': {'references': [{'pmid': '16045553', 'type': 'BACKGROUND', 'citation': 'Resim S, Ekerbicer H, Ciftci A. Effect of tamsulosin on the number and intensity of ureteral colic in patients with lower ureteral calculus. Int J Urol. 2005 Jul;12(7):615-20. doi: 10.1111/j.1442-2042.2005.01116.x.'}, {'pmid': '8957159', 'type': 'BACKGROUND', 'citation': 'Wilde MI, McTavish D. Tamsulosin. A review of its pharmacological properties and therapeutic potential in the management of symptomatic benign prostatic hyperplasia. Drugs. 1996 Dec;52(6):883-98. doi: 10.2165/00003495-199652060-00012.'}, {'pmid': '21149761', 'type': 'DERIVED', 'citation': 'Vincendeau S, Bellissant E, Houlgatte A, Dore B, Bruyere F, Renault A, Mouchel C, Bensalah K, Guille F; Tamsulosin Study Group. Tamsulosin hydrochloride vs placebo for management of distal ureteral stones: a multicentric, randomized, double-blind trial. Arch Intern Med. 2010 Dec 13;170(22):2021-7. doi: 10.1001/archinternmed.2010.447.'}]}, 'descriptionModule': {'briefSummary': 'Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.', 'detailedDescription': 'Ureteral colic, mainly due to ureterolithiasis, represents 1 to 2% of hospital emergency admissions. When a surgical intervention is not required, usual treatment combines hydration and anti-inflammatory drugs.\n\nAlpha1-blockers, firstly developed as anti-hypertensive drugs, are now also used in the management of benign prostatic hyperplasia, due to their relaxing properties on the urinary tract. The aim of the study is to investigate whether tamsulosin could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis. Patients are randomized to receive either tamsulosin or a placebo in addition to usual treatment until stone elimination. Efficacy is assessed by evaluating the time to spontaneous passage of the stone between day 1 and day 42, the need for surgery and pain recurrences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult over 18 years\n* Emergency admission for a ureteral colic\n* Radio-opaque ureterolithiasis\n* Stone of 2 to 7 mm diameter\n* Informed written consent\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding\n* Treatment with alpha or beta-blocker\n* Contraindication to tamsulosin (orthostatic hypertension, hepatic failure)\n* Complication needing surgery\n* Calculi spontaneous passage before randomization\n* Patient not available for a 6 week follow-up'}, 'identificationModule': {'nctId': 'NCT00151567', 'acronym': 'TAMSULOSINE', 'briefTitle': 'Evaluation of Tamsulosin in the Treatment of Ureteral Stones', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones', 'orgStudyIdInfo': {'id': 'AFSSAPS 010751'}, 'secondaryIdInfos': [{'id': 'PHRC/00-01', 'type': 'OTHER', 'domain': 'Rennes University Hospital'}, {'id': 'CIC0203/004'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Tamsulosin', 'interventionNames': ['Drug: Tamsulosin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tamsulosin', 'type': 'DRUG', 'description': 'Oral tamsulosin once a day until stone elimination or the end of the follow-up (42 days)', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral placebo of tamsulosin once a day until stone elimination or the end of the follow-up (42 days)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': "Service d'Urologie- Hôpital du Val de Grâce", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': "Service d'Urologie - Hôpital de La Milétrie", 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35600', 'city': 'Redon', 'country': 'France', 'facility': 'Hôpital de Redon', 'geoPoint': {'lat': 47.65165, 'lon': -2.08421}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': "Service d'Urologie- Hôpital Robert Debré", 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': "Service d'Urologie- Hôpital Pontchaillou", 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': "Service d'Urologie - Hôpital Bretonneau", 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Francois Guillé, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}, {'name': 'Eric Bellissant, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}, {'name': 'Yamanouchi', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Direction of Clinical Research', 'oldOrganization': 'Rennes University Hospital'}}}}