Kidney Calculi Clinical Trial
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute | Manoj, Monga, M.D. |
United States,
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 |
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