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ALF-STONE: Alfuzosin in Uretheric Stones

This study has been terminated.
(Discontinued due to incomplete recruitment)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00454402
First received: March 29, 2007
Last updated: September 21, 2007
Last verified: September 2007
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Alfuzosin in Uretheric Stones

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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
Investigators
Study Director: Carlos Santos, MD Sanofi
  More Information

No publications provided

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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Alfuzosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013