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WithdrawnNCT00583258Updated Jul 31, 2015

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

An interventional study of Alfuzosin (Xatral) and Placebo Alfuzosin in Kidney Stones, sponsored by Unity Health Toronto. Withdrawn at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Kidney Stones
03

In context

Kidney Calculi

597 studies on the registry are indexed under Kidney Calculi; 162 are open to participants now.

Browse Kidney Calculi studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    A

    Drug: Alfuzosin (Xatral)

  • Placebo comparator
    B

    Drug: Placebo Alfuzosin

Interventions

  • DrugAlfuzosin (Xatral)

    10 mg PO once a day

  • DrugPlacebo Alfuzosin

    10 mg PO once a day

06

What researchers measure

Primary outcomes

  1. The primary outcome will be Cox proportional hazards survival analysis of stone passage over time

    Time frame: 4 weeks

Secondary outcomes

  1. Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates

    Time frame: 4 weeks

07

Study locations

1 site
  • St. Michael's Hospital
    Toronto, Ontario M5B 1W8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00583258
Lead sponsor
Unity Health Toronto
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Dec 31, 2007
Start date
Oct 2007
Primary completion
Sep 2009
Completion
Oct 2009
Last update
Jul 31, 2015

Study contacts

Kenneth A Pace, MD, FRCSC
principal investigator · Unity Health Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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