Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

Completed · Phase 3 · Has a placebo group

Conditions studied: Kidney Calculi, Ureteral Calculi, Colic

In brief

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.

Key facts

Study ID

NCT00177086

Run by

University of Minnesota

People needed

76

Starts

2005-09-01

Expected to finish

2008-01-01

Last updated by the study team

2013-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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