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

Kidney Stones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00583258
• Other study ID #: SMHXATRAL2007
• Secondary ID: ALFUS-L-00811
• Status: Withdrawn
• Phase: N/A
• First received: December 20, 2007
• Last updated: July 30, 2015
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: July 2015
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stones
• Nephrolithiasis

Intervention

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

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be Cox proportional hazards survival analysis of stone passage over time		4 weeks	No
Secondary	Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates		4 weeks	No