ALF-STONE: Alfuzosin in Uretheric Stones - Full Text View

Purpose

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).

Condition	Intervention	Phase
Prostatic Hyperplasia	Drug: Alfuzosin	Phase III

Drug Information available for:

Alfuzosin Alfuzosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Alfuzosin in Uretheric Stones

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Safety: General clinical safety by collection of spontaneously reported adverse events [ Time Frame: at each visit ]
Efficacy: Percentage of patients without imagiologic evidence of any stone [ Time Frame: 72h to 96 hours after ESWL ]

Secondary Outcome Measures:

Percentage of patients without imagiologic evidence of any stone [ Time Frame: 24 hours after ESWL ]
Percentage of patients with clinical evidence of stones clearance [ Time Frame: 72h to 96 hours after ESWL ]
Time for stone clearance (clinical evaluation)
Numeric Rating Scale scores [ Time Frame: at 24h, (48h, if applicable), 72-96h and 7 days ]
Need for rescue analgesic medication.

Estimated Enrollment:	220
Study Start Date:	August 2006
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454402

Locations


Portugal
	Sanofi-Aventis
	Lisbon, Portugal

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	Carlos Santos, MD	Sanofi-Aventis

More Information

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Study ID Numbers:	L_9795, EudraCT # : 2005-005481-36
First Received:	March 29, 2007
Last Updated:	September 21, 2007
ClinicalTrials.gov Identifier:	NCT00454402
Health Authority:	Portugal: National Pharmacy and Medicines Institute

Study placed in the following topic categories:

Hyperplasia

Alfuzosin

Prostatic Diseases

Prostatic Hyperplasia

Genital Diseases, Male

Calculi

Additional relevant MeSH terms:

Neurotransmitter Agents

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Therapeutic Uses

Physiological Effects of Drugs

Adrenergic Antagonists

Cardiovascular Agents

Adrenergic alpha-Antagonists

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00454402