Status:
COMPLETED
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Manoj, Monga, M.D.
Conditions:
Kidney Calculi
Ureteral Calculi
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Age =\>18
- \<8mm ureteral calculus below the pelvic brim identified by non-contrast CT scan and/or intravenous pyelogram
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00177086
Start Date
September 1 2005
End Date
January 1 2008
Last Update
March 18 2013
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455