This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

ALF-STONE: Alfuzosin in Uretheric Stones

This study has been terminated.
(Discontinued due to incomplete recruitment)
Information provided by:
Sanofi Identifier:
First received: March 29, 2007
Last updated: September 21, 2007
Last verified: September 2007

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00454402

Lisbon, Portugal
Sponsors and Collaborators
Study Director: Carlos Santos, MD Sanofi
  More Information 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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
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 processed this record on August 18, 2017