Official Title: “Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Other: Alfuzosin Hydrochloride
  • One tablet every day for 4 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Alfuzosin
• Placebo Comparator: Placebo

Primary Measures

• Spontaneous stone passage for distal ureteral calculi
  • Time Frame: increased
    Safety Issue?: No

Secondary Measures

• Decrease the pain and narcotic use associated with stone passage
  • Time Frame: decrease
    Safety Issue?: No
• Decrease the time to spontaneous passage
  • Time Frame: decrease
    Safety Issue?: No
• Shift the size distribution of stones passed towards larger sizes
  • Time Frame: unknown
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Minnesota

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00177086

Study ID Number: 0412M65851

ClinicalTrials.gov Identifier: NCT00177086

Health Authority: United States: Food and Drug Administration