Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi - Full Text View

Sponsors and Collaborators:	University of Minnesota Manoj, Monga, M.D.
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00177086

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 III

Drug Information available for: Alfuzosin Alfuzosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

Further study details as provided by University of Minnesota:

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
Alfuzosin: Experimental	Other: Alfuzosin Hydrochloride One tablet every day for 4 weeks
Placebo: Placebo Comparator	Other: Alfuzosin Hydrochloride One tablet every day for 4 weeks

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

Manoj, Monga, M.D.

Investigators

Principal Investigator:

Manoj Monga, MD

University of Minnesota and VAMC Minneapolis

More Information

Responsible Party:	University of Minnesota ( Manoj Monga, MD )
Study ID Numbers:	0412M65851, L9839, 3579B
Study First Received:	September 13, 2005
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00177086
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Urolithiasis
Colic
Ureteral Calculi
Ureteral Diseases
Calculi

Ureterolithiasis
Alfuzosin
Urologic Diseases
Kidney Diseases
Nephrolithiasis
Kidney Calculi

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs

Adrenergic Antagonists
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009