A Randomized Study of Whether Alfuzosin(Xatral) Helps in... | NCT00583258

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

NCT00583258

Sponsor

Unity Health Toronto

Status

Withdrawn

Last Update Posted

Jul 31, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Kidney Stones

Interventions

Alfuzosin (Xatral)
Placebo Alfuzosin

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ALFUS-L-00811

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Sep 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 20, 2007

First Posted Date

Dec 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2015

Last Update Posted Date

Jul 31, 2015Estimated

Name	Class
Sanofi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: Alfuzosin (Xatral)
B	Placebo Comparator		Drug: Placebo Alfuzosin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alfuzosin (Xatral)	Drug	10 mg PO once a day	A
Placebo Alfuzosin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome will be Cox proportional hazards survival analysis of stone passage over time		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Secondary outcomes will be stone passage rates, pain scores, intervention rates, hospitalization rates and complication rates		4 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth A Pace, MD, FRCSC	Unity Health Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Michael's Hospital		Toronto	Ontario	M5B 1W8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C047638	alfuzosin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided