We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

ALF-STONE: Alfuzosin in Uretheric Stones

This study has been terminated.
(Discontinued due to incomplete recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00454402
First Posted: March 30, 2007
Last Update Posted: September 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Alfuzosin in Uretheric Stones

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454402


Locations
Portugal
Sanofi-Aventis
Lisbon, Portugal
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Carlos Santos, MD Sanofi
  More Information

ClinicalTrials.gov Identifier: NCT00454402     History of Changes
Other Study ID Numbers: L_9795
EudraCT # : 2005-005481-36
First Submitted: March 29, 2007
First Posted: March 30, 2007
Last Update Posted: September 24, 2007
Last Verified: September 2007

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