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

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.

Study Type: Interventional

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

Study Primary Completion Date: September 2009

Intervention(s) in this Clinical Trial

• Drug: Alfuzosin (Xatral)
  • 10 mg PO once a day
• Drug: Placebo Alfuzosin
  • 10 mg PO once a day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Placebo Comparator: B

Primary Measures

• The primary outcome will be Cox proportional hazards survival analysis of stone passage over time
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates
  • Time Frame: 4 weeks
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: St. Michael's Hospital, Toronto

Overall Clinical Trial Officials and Contacts

Kenneth A Pace, MD, FRCSC Principal Investigator St. Michael's Hospital, Toronto  

Overall Contact: Daniela Ghiculete, MSc 416-864-6060 ghiculeted@smh.toronto.on.ca

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00583258

Study ID Number: SMHXATRAL2007

ClinicalTrials.gov Identifier: NCT00583258

Health Authority: Canada: Health Canada