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

This study has been terminated.
Sponsor:
Collaborator:
Sanofi
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00583258
First received: December 20, 2007
Last updated: August 4, 2009
Last verified: July 2009
  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: 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 ]

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
Experimental: A Drug: Alfuzosin (Xatral)
10 mg PO once a day
Placebo Comparator: B 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
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, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Dr. Kenneth A. Pace, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT00583258     History of Changes
Other Study ID Numbers: SMHXATRAL2007, ALFUS-L-00811
Study First Received: December 20, 2007
Last Updated: August 4, 2009
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 23, 2014