We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00177086
First Posted: September 15, 2005
Last Update Posted: March 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Manoj, Monga, M.D.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Decrease the pain and narcotic use associated with stone passage [ Time Frame: decrease ]
  • Decrease the time to spontaneous passage [ Time Frame: decrease ]
  • Shift the size distribution of stones passed towards larger sizes

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00177086     History of Changes
Other Study ID Numbers: 0412M65851
L9839
3579B
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: March 18, 2013
Last Verified: March 2013

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