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

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
First received: December 20, 2007
Last updated: July 30, 2015
Last verified: July 2015
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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi

Resource links provided by NLM:

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 ]

Enrollment: 0
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Alfuzosin (Xatral)
10 mg PO once a day
Placebo Comparator: B Drug: Placebo Alfuzosin
10 mg PO once a day


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

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

Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Principal Investigator: Kenneth A Pace, MD, FRCSC St. Michael's Hospital, Toronto
  More Information

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00583258     History of Changes
Other Study ID Numbers: SMHXATRAL2007  ALFUS-L-00811 
Study First Received: December 20, 2007
Last Updated: July 30, 2015
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Kidney Calculi
Kidney Diseases
Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on May 03, 2016