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

Primary Purpose

Kidney Stones

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Alfuzosin (Xatral)
Placebo Alfuzosin
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2007
Last Updated
July 30, 2015
Sponsor
Unity Health Toronto
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00583258
Brief Title
A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones
Official Title
A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Withdrawn
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Alfuzosin (Xatral)
Intervention Description
10 mg PO once a day
Intervention Type
Drug
Intervention Name(s)
Placebo Alfuzosin
Intervention Description
10 mg PO once a day
Primary Outcome Measure Information:
Title
The primary outcome will be Cox proportional hazards survival analysis of stone passage over time
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth A Pace, MD, FRCSC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

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

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