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Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

This study has been completed.
Sponsor:
Collaborator:
Manoj, Monga, M.D.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00177086
First received: September 13, 2005
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Calculi
Ureteral Calculi
Colic
 Other: Alfuzosin Hydrochloride
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Spontaneous stone passage for distal ureteral calculi [ Time Frame: increased ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease the pain and narcotic use associated with stone passage [ Time Frame: decrease ] [ Designated as safety issue: No ]
  • Decrease the time to spontaneous passage [ Time Frame: decrease ] [ Designated as safety issue: No ]
  • Shift the size distribution of stones passed towards larger sizes [ Time Frame: unknown ] [ Designated as safety issue: Yes ]

Enrollment: 76
Study Start Date: September 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alfuzosin Other: Alfuzosin Hydrochloride
One tablet every day for 4 weeks
Other Name: Sugar pill
Placebo Comparator: Placebo Other: Alfuzosin Hydrochloride
One tablet every day for 4 weeks
Other Name: Sugar pill

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177086

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Manoj, Monga, M.D.
Investigators
Principal Investigator: Manoj Monga, MD University of Minnesota and VAMC Minneapolis
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00177086     History of Changes
Other Study ID Numbers: 0412M65851, L9839, 3579B
Study First Received: September 13, 2005
Last Updated: March 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Ureteral Diseases
Alfuzosin
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013