NCT00177086CompletedPhase 3
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- Spontaneous stone passage for distal ureteral calculi
Study Overview
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 with stone passage, decrease of the time to spontaneous stone passage, shift in the size distribution of stones passed towards larger sizes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Spontaneous stone passage for distal ureteral calculi
Time Frame: increased
Secondary Outcomes
- Decrease the pain and narcotic use associated with stone passage(decrease)
- Decrease the time to spontaneous passage(decrease)
- Shift the size distribution of stones passed towards larger sizes
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Terminated
Phase 3
ALF-STONE: Alfuzosin in Uretheric StonesProstatic HyperplasiaNCT00454402Sanofi220
Active, not recruiting
Not Applicable
Alfuzosin in Uretheric Stones - ALF-STONEEUCTR2005-005481-36-PTSanofi-Synthelabo Produtos Farmaceuticos, S.A.220
Recruiting
Phase 3
Silodosin vs Tamsulosin as METStone, UrinaryNCT05570084Princess Margaret Hospital, Hong Kong80
Withdrawn
Phase 3
Use of Alfuzosin in Stone Treatment With ESWLUrinary CalculiNCT00388271Singapore General Hospital
Completed
Phase 3
Clinical Trial in Males With BPH (Enlarged Prostate)Urinary RetentionProstatic HyperplasiaBenign Prostatic HypertrophyNCT00029822Sanofi1,522
