Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status and phase

Completed
Phase 3

Conditions

Ureteral Calculi
Kidney Calculi
Colic

Treatments

Other: Alfuzosin Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00177086
0412M65851
L9839
3579B

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

76 participants in 2 patient groups, including a placebo group

Alfuzosin
Experimental group
Treatment:
Other: Alfuzosin Hydrochloride
Placebo
Placebo Comparator group
Treatment:
Other: Alfuzosin Hydrochloride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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