Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

NCT ID: NCT00177086

Last Updated: 2013-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-01-31

Brief Summary

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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

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Conditions

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Kidney Calculi Ureteral Calculi Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Alfuzosin

Group Type EXPERIMENTAL

Alfuzosin Hydrochloride

Intervention Type OTHER

One tablet every day for 4 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Alfuzosin Hydrochloride

Intervention Type OTHER

One tablet every day for 4 weeks

Interventions

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Alfuzosin Hydrochloride

One tablet every day for 4 weeks

Intervention Type OTHER

Other Intervention Names

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Sugar pill

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Manoj, Monga, M.D.

INDIV

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manoj Monga, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota and VAMC Minneapolis

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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L9839

Identifier Type: -

Identifier Source: secondary_id

3579B

Identifier Type: -

Identifier Source: secondary_id

0412M65851

Identifier Type: -

Identifier Source: org_study_id

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