Alfuzosin Hydrochloride to Promote Passage of Distal Uret... | NCT00177086

Studies
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

NCT00177086

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Mar 18, 2013Estimated

Enrollment

76Actual

Phase

Phase 3

Conditions

Kidney Calculi
Ureteral Calculi
Colic

Interventions

Alfuzosin Hydrochloride

Countries

United States

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

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

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

Mar 15, 2013

Last Update Posted Date

Mar 18, 2013Estimated

Name	Class
Manoj, Monga, M.D.	INDIV

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

This study will assess improvement in the percentage of spontaneous stone passage for distal ureteral calculi for alfuzosin compared to placebo, decrease of pain and narcotic/analgesic use associated with stone passage, decrease of the time to spontaneous stone passage, shift in the size distribution of stones passed towards larger sizes.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alfuzosin	Experimental		Other: Alfuzosin Hydrochloride
Placebo	Placebo Comparator		Other: Alfuzosin Hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alfuzosin Hydrochloride	Other	One tablet every day for 4 weeks	Alfuzosin Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spontaneous stone passage for distal ureteral calculi		increased

Secondary Outcomes

Measure	Description	Time Frame
Decrease the pain and narcotic use associated with stone passage		decrease
Decrease the time to spontaneous passage		decrease
Shift the size distribution of stones passed towards larger sizes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age =>18
<8mm ureteral calculus below the pelvic brim identified by non-contrast CT scan and/or intravenous pyelogram

Exclusion Criteria:

Subject with know hypersensitivity to Alfuzosin hydrochloride or any component of Alfuzosin hydrochloride tablets
Pregnant/Nursing females
Solitary kidney
Renal insufficiency (Creatinine>1.8)
Urinary infection (fever >101, positive urine culture, many bacteria on urinalysis)
Moderate or severe hepatic insufficiency (Childs-Pugh categories B and C)
Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since Alfuzosin blood levels are increased
Other alpha-blockers
Phosphodiesterase type 5 inhibitors for erectile dysfunction
Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manoj Monga, MD	University of Minnesota and VAMC Minneapolis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi
D014514	Ureteral Calculi
D003085	Colic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
L9839
3579B

ID	Term
C047638	alfuzosin
D000073893	Sugars