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

This study is currently recruiting participants.

Verified by St. Michael's Hospital, Toronto, June 2009

First Received: December 20, 2007 Last Updated: June 2, 2009 History of Changes

Sponsors and Collaborators:	St. Michael's Hospital, Toronto Sanofi-Aventis
Information provided by:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT00583258

Purpose

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.

Condition	Intervention
Kidney Stones	Drug: Alfuzosin (Xatral) Drug: Placebo Alfuzosin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi

Resource links provided by NLM:

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Alfuzosin (Xatral) 10 mg PO once a day
B: Placebo Comparator	Drug: Placebo Alfuzosin 10 mg PO once a day

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583258

Contacts

Contact: Daniela Ghiculete, MSc

416-864-6060 ext 6344

ghiculeted@smh.toronto.on.ca

Locations

Canada, Ontario
St. Michael's Hospital	Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Daniela Ghiculete, MSc 416-864-6060 ext 6344 ghiculeted@smh.toronto.on.ca
Sub-Investigator: John D Honey, MR, FRCSC

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Sanofi-Aventis

Investigators

Principal Investigator:

Kenneth A Pace, MD, FRCSC

St. Michael's Hospital, Toronto

More Information

No publications provided

Responsible Party:	St. Michael's Hospital ( Dr. Kenneth A. Pace )
Study ID Numbers:	SMHXATRAL2007, ALFUS-L-00811
Study First Received:	December 20, 2007
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00583258 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Neurotransmitter Agents
Adrenergic Agents
Urolithiasis
Ureteral Calculi
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents

Calculi
Ureterolithiasis
Alfuzosin
Urologic Diseases
Adrenergic Antagonists
Kidney Diseases
Nephrolithiasis
Kidney Calculi

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Urolithiasis
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents

Calculi
Pharmacologic Actions
Alfuzosin
Urologic Diseases
Therapeutic Uses
Adrenergic Antagonists
Kidney Diseases
Nephrolithiasis
Kidney Calculi

ClinicalTrials.gov processed this record on July 06, 2009