A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones - Tabular View

Tracking Information

First Received Date ^ICMJE

December 20, 2007

Last Updated Date

August 4, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary outcome will be Cox proportional hazards survival analysis of stone passage over time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00583258 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones

Official Title ^ICMJE

A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi

Brief Summary

Patients who present for the first time to Emergency Room with renal colic due to a distal ureteral calculus (as diagnosed with spiral CT scan and KUB) will be randomized to receive Xatral 10mg po once a day or placebo once discharged from the ER. The purpose of this study is to assess if patients treated with Xatral will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Kidney Stones

Intervention ^ICMJE

Drug: Alfuzosin (Xatral)
Drug: Placebo Alfuzosin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

October 2009

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

first presentation to ER with renal colic secondary to a distal ureteral stone diagnosed on spiral CT scan
stone radiopaque on KUB, distal to the sacro-iliac joint
patient suitable for discharge from ER
patient willing to return for follow-up on a weekly basis for maximum 4 visits

Exclusion Criteria:

more than one ureteral calculi
radiolucent stones or cystine stones
prior ipsilateral calculus or ureteral surgery
congenital anomalies of the ureter
patients presents with an absolute indication for intervention
allergy or contraindication to NSAIDs (history of orthostatic hypotension, current systolic BP <90 mmHg)
patient currently taking an alpha-blocker
hepatic insufficiency
pregnancy

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00583258

Responsible Party

Dr. Kenneth A. Pace, St. Michael's Hospital

Study ID Numbers ^ICMJE

SMHXATRAL2007, ALFUS-L-00811

Study Sponsor ^ICMJE

St. Michael's Hospital, Toronto

Collaborators ^ICMJE

Sanofi-Aventis

Investigators ^ICMJE

Principal Investigator:

Kenneth A Pace, MD, FRCSC

St. Michael's Hospital, Toronto

Information Provided By

St. Michael's Hospital, Toronto

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP