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ALF-STONE: Alfuzosin in Uretheric Stones

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatic Hyperplasia

Intervention: Alfuzosin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Carlos Santos, MD, Study Director, Affiliation: Sanofi

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).

Clinical Details

Official title: Alfuzosin in Uretheric Stones

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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

Efficacy: Percentage of patients without imagiologic evidence of any stone

Secondary outcome:

Percentage of patients without imagiologic evidence of any stone

Percentage of patients with clinical evidence of stones clearance

Time for stone clearance (clinical evaluation)

Numeric Rating Scale scores

Need for rescue analgesic medication.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Sanofi-Aventis, Lisbon, Portugal
Additional Information

Starting date: August 2006
Last updated: September 21, 2007

Page last updated: August 23, 2015

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