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Completed

NCT Number: NCT00177086

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.

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Key information

Conditions

Kidney Calculi Calculi Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ureteral Calculi Ureteral Diseases Ureterolithiasis Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alfuzosin Hydrochloride

Other

One tablet every day for 4 weeks

Other names: Sugar pill

Primary outcomes

  1. Spontaneous stone passage for distal ureteral calculi

    Time frame: increased

Secondary outcomes

  1. Decrease the pain and narcotic use associated with stone passage

    Time frame: decrease

  2. Decrease the time to spontaneous passage

    Time frame: decrease

  3. Shift the size distribution of stones passed towards larger sizes

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Manoj, Monga, M.D.

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 15, 2005
Registry last updated
Mar 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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