Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

Phase 3

Completed

• Conditions: Kidney Calculi; Ureteral Calculi; Colic
• Interventions: Other: Alfuzosin Hydrochloride

• Registration Number: NCT00177086
• Lead Sponsor: University of Minnesota

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 available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-15
• Last Update Posted: 2013-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alfuzosin	Alfuzosin Hydrochloride	-
Placebo	Alfuzosin Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Spontaneous stone passage for distal ureteral calculi	increased

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States