NCT00454402

Brief Summary

The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours. This study will also specifically focus on the evaluation of time of stone clearance and of pain reduction (Numeric Rating Scale).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

September 24, 2007

Status Verified

September 1, 2007

First QC Date

March 29, 2007

Last Update Submit

September 21, 2007

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

  • Safety: General clinical safety by collection of spontaneously reported adverse events

    at each visit

  • Efficacy: Percentage of patients without imagiologic evidence of any stone

    72h to 96 hours after ESWL

Secondary Outcomes (5)

  • Percentage of patients without imagiologic evidence of any stone

    24 hours after ESWL

  • Percentage of patients with clinical evidence of stones clearance

    72h to 96 hours after ESWL

  • Time for stone clearance (clinical evaluation)

  • Numeric Rating Scale scores

    at 24h, (48h, if applicable), 72-96h and 7 days

  • Need for rescue analgesic medication.

Interventions

AlfuzosinDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with imagiologic evidence of uretheric stones

You may not qualify if:

  • Women pregnant or breast feeding
  • Patients with renal impairment (creatinine \> 2mg/dl)
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Lisbon, Portugal

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Carlos Santos, MD

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 29, 2007

First Posted

March 30, 2007

Study Start

August 1, 2006

Study Completion

July 1, 2007

Last Updated

September 24, 2007

Record last verified: 2007-09

Locations

PT(1)