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Sponsors and Collaborators: |
St. Michael's Hospital, Toronto Sanofi-Aventis |
Information provided by: | St. Michael's Hospital, Toronto |
ClinicalTrials.gov Identifier: | NCT00583258 |
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.
Condition | Intervention |
Kidney Stones |
Drug: Alfuzosin (Xatral) Drug: Placebo Alfuzosin |
Drug Information available for: | Alfuzosin Alfuzosin hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi |
Estimated Enrollment: | 200 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental |
Drug: Alfuzosin (Xatral)
10 mg PO once a day
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B: Placebo Comparator |
Drug: Placebo Alfuzosin
10 mg PO once a day
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniela Ghiculete, MSc | 416-864-6060 ext 6344 | ghiculeted@smh.toronto.on.ca |
Canada, Ontario | |||||
St. Michael's Hospital | Recruiting | ||||
Toronto, Ontario, Canada, M5B 1W8 | |||||
Contact: Daniela Ghiculete, MSc 416-864-6060 ext 6344 ghiculeted@smh.toronto.on.ca | |||||
Sub-Investigator: John D Honey, MR, FRCSC |
St. Michael's Hospital, Toronto |
Sanofi-Aventis |
Principal Investigator: | Kenneth A Pace, MD, FRCSC | St. Michael's Hospital, Toronto |
Responsible Party: | St. Michael's Hospital ( Dr. Kenneth A. Pace ) |
Study ID Numbers: | SMHXATRAL2007, ALFUS-L-00811 |
First Received: | December 20, 2007 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00583258 |
Health Authority: | Canada: Health Canada |
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