A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones
A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
December 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJuly 31, 2015
July 1, 2015
1.9 years
December 20, 2007
July 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome will be Cox proportional hazards survival analysis of stone passage over time
4 weeks
Secondary Outcomes (1)
Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates
4 weeks
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- Sanoficollaborator
Study Sites (1)
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth A Pace, MD, FRCSC
Unity Health Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
December 31, 2007
Study Start
October 1, 2007
Primary Completion
September 1, 2009
Study Completion
October 1, 2009
Last Updated
July 31, 2015
Record last verified: 2015-07