NCT00177086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

2.3 years

First QC Date

September 13, 2005

Last Update Submit

March 15, 2013

Conditions

Kidney CalculiUreteral CalculiColic

Outcome Measures

Primary Outcomes (1)

  • Spontaneous stone passage for distal ureteral calculi

    increased

Secondary Outcomes (3)

  • Decrease the pain and narcotic use associated with stone passage

    decrease

  • Decrease the time to spontaneous passage

    decrease

  • Shift the size distribution of stones passed towards larger sizes

Study Arms (2)

Alfuzosin

EXPERIMENTAL
Other: Alfuzosin Hydrochloride

Placebo

PLACEBO COMPARATOR
Other: Alfuzosin Hydrochloride

Interventions

Alfuzosin HydrochlorideOTHER

One tablet every day for 4 weeks

Also known as: Sugar pill
AlfuzosinPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age =\>18
  • \<8mm ureteral calculus below the pelvic brim identified by non-contrast CT scan and/or intravenous pyelogram

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Kidney CalculiUreteral CalculiColic

Interventions

alfuzosinSugars

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUreterolithiasisUreteral DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Manoj Monga, MD

    University of Minnesota and VAMC Minneapolis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

September 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations

US(1)