Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

Kidney Calculi Clinical Trial

Official title:

Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177086
• Other study ID #: 0412M65851
• Secondary ID: L98393579B
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 15, 2013
• Start date: September 2005
• Est. completion date: January 2008

Study information

• Verified date: March 2013
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Colic
• Kidney Calculi
• Ureteral Calculi
• Ureterolithiasis

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Manoj, Monga, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous stone passage for distal ureteral calculi		increased	No
Secondary	Decrease the pain and narcotic use associated with stone passage		decrease	No
Secondary	Decrease the time to spontaneous passage		decrease	No
Secondary	Shift the size distribution of stones passed towards larger sizes		unknown	Yes