Back to resultsAlfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi
Primary Purpose
Kidney Calculi, Ureteral Calculi, Colic
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Alfuzosin Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Calculi
Eligibility 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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Alfuzosin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Spontaneous stone passage for distal ureteral calculi
Secondary Outcome Measures
Decrease the pain and narcotic use associated with stone passage
Decrease the time to spontaneous passage
Shift the size distribution of stones passed towards larger sizes
Full Information
NCT ID
NCT00177086
First Posted
September 13, 2005
Last Updated
March 15, 2013
Sponsor
University of Minnesota
Collaborators
Manoj, Monga, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT00177086
Brief Title
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi
Official Title
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Manoj, Monga, M.D.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi, Ureteral Calculi, Colic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alfuzosin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Alfuzosin Hydrochloride
Other Intervention Name(s)
Sugar pill
Intervention Description
One tablet every day for 4 weeks
Primary Outcome Measure Information:
Title
Spontaneous stone passage for distal ureteral calculi
Time Frame
increased
Secondary Outcome Measure Information:
Title
Decrease the pain and narcotic use associated with stone passage
Time Frame
decrease
Title
Decrease the time to spontaneous passage
Time Frame
decrease
Title
Shift the size distribution of stones passed towards larger sizes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj Monga, MD
Organizational Affiliation
University of Minnesota and VAMC Minneapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi
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