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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00583258
Recruitment Status : Withdrawn
First Posted : December 31, 2007
Last Update Posted : July 31, 2015
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.

Condition or disease Intervention/treatment Phase
Kidney Stones Drug: Alfuzosin (Xatral) Drug: Placebo Alfuzosin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Experimental: A Drug: Alfuzosin (Xatral)
10 mg PO once a day

Placebo Comparator: B Drug: Placebo Alfuzosin
10 mg PO once a day

Primary Outcome Measures :
  1. The primary outcome will be Cox proportional hazards survival analysis of stone passage over time [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00583258

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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
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Principal Investigator: Kenneth A Pace, MD, FRCSC St. Michael's Hospital, Toronto
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Responsible Party: St. Michael's Hospital, Toronto Identifier: NCT00583258    
Other Study ID Numbers: SMHXATRAL2007
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Kidney Calculi
Kidney Diseases
Urologic Diseases
Urinary Calculi
Pathological Conditions, Anatomical
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents