ALF-STONE: Alfuzosin in Uretheric Stones

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Alfuzosin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with imagiologic evidence of uretheric stones

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Carlos Santos, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Lisbon, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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EudraCT # : 2005-005481-36

Identifier Type: -

Identifier Source: secondary_id

L_9795