NCT00409227

Brief Summary

In latest literature more evidence is available about the positive effect of alpha blocker on stone expulsion from the ureter. Patients benefit from less pain and shortening time to stone expulsion. Our study is design to evaluate whether alfuzosin improves the stone free out come following SWL.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Last Updated

June 18, 2008

Status Verified

June 1, 2008

Enrollment Period

2.6 years

First QC Date

December 7, 2006

Last Update Submit

June 17, 2008

Conditions

UrolithiasisNephrolithiasisUreterolithiasis

Keywords

swllithotripsystone diseaseurolithiasisnephrolithiasis

Outcome Measures

Primary Outcomes (7)

  • use of pain control medication stone free rates

    3 months

  • pain visual analogue scale

    3 month

  • side effects

    3 months

  • stone free rate

    3 months

  • time to stone free status

    3 months

  • need for secondary procedures

    3 months

  • auxiliary procedures

    3 months

Study Arms (2)

1

ACTIVE COMPARATOR

double blind placebo control

Drug: Alpha blocker-alfuzosin

2

PLACEBO COMPARATOR

placebo control blinded arm

Drug: placebo

Interventions

Alpha blocker-alfuzosinDRUG

P.O. alfuzosin 10 mg once a day

1
placeboDRUG

placebo once a day for 3 months or stone free

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing shock wave lithotripsy treatment for urolithiasis.

You may not qualify if:

  • patients with abnormal liver function, postural hypotension, alpha-blocker treatment, sensitivity to alpha-blockers, radio-lucent stone, calcium channel blocker treatment, steroids treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endourology unit Urology department Assaf Harofeh MC

Ẕerifin, 40700, Israel

RECRUITING

MeSH Terms

Conditions

UrolithiasisNephrolithiasisUreterolithiasis

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesKidney DiseasesUreteral Diseases

Study Officials

  • yoram I siegel, MD

    Endourology unit Urology department Assaf harofeh MC.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

yoram I siegel, MD

CONTACT

972-577-345408ysiegel@asaf.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

December 1, 2006

Primary Completion

July 1, 2009

Last Updated

June 18, 2008

Record last verified: 2008-06

Locations

IL(1)