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

• Sponsor: Unity Health Toronto (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00583258
• Collaborator: Sanofi (Industry)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stones	Drug: Alfuzosin (Xatral); Drug: Placebo Alfuzosin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blinded Placebo-Controlled Trial of Alfuzosin (Xatral)in the Management of Distal Ureteral Calculi
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: Alfuzosin (Xatral); 10 mg PO once a day
Placebo Comparator: B	Drug: Placebo Alfuzosin; 10 mg PO once a day

Outcome Measures

Primary Outcome Measures

1. The primary outcome will be Cox proportional hazards survival analysis of stone passage over time [4 weeks]

Secondary Outcome Measures

1. Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8

Sponsors and Collaborators

• Unity Health Toronto
• Sanofi

Investigators

• Principal Investigator: Kenneth A Pace, MD, FRCSC, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT00583258
• Other Study ID Numbers: SMHXATRAL2007; ALFUS-L-00811
• First Posted: Dec 31, 2007
• Last Update Posted: Jul 31, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis; Alfuzosin

Study Results

No Results Posted as of Jul 31, 2015