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Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT00177086
Collaborator
Manoj, Monga, M.D. (Other)
76
Enrollment
1
Location
2
Arms
28
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Alfuzosin Hydrochloride
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alfuzosin

Other: Alfuzosin Hydrochloride
One tablet every day for 4 weeks
Other Names:
  • Sugar pill

    		•
    Placebo Comparator: Placebo

    Other: Alfuzosin Hydrochloride
    One tablet every day for 4 weeks
    Other Names:
  • Sugar pill

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Spontaneous stone passage for distal ureteral calculi [increased]

    Secondary Outcome Measures

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

    2. Decrease the time to spontaneous passage [decrease]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • University of Minnesota
    • Manoj, Monga, M.D.

    Investigators

    • Principal Investigator: Manoj Monga, MD, University of Minnesota and VAMC Minneapolis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00177086
    Other Study ID Numbers:
    • 0412M65851
    • L9839
    • 3579B
    First Posted:
    Sep 15, 2005
    Last Update Posted:
    Mar 18, 2013
    Last Verified:
    Mar 1, 2013
    Additional relevant MeSH terms:
    Kidney Calculi
    Nephrolithiasis
    Ureteral Calculi
    Ureterolithiasis
    Calculi
    Alfuzosin

    Study Results

    No Results Posted as of Mar 18, 2013