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Clinical Trials/NCT00177086
NCT00177086CompletedPhase 3

Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

University of Minnesota2 sites in 1 country76 target enrollmentStarted: September 2005Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
76
Locations
2
Primary Endpoint
Spontaneous stone passage for distal ureteral calculi
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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