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ALF-STONE: Alfuzosin in Uretheric Stones

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.
ClinicalTrials.gov Identifier: NCT00454402
Recruitment Status : Terminated (Discontinued due to incomplete recruitment)
First Posted : March 30, 2007
Last Update Posted : September 24, 2007
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Brief 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).

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Drug: Alfuzosin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Alfuzosin in Uretheric Stones
Study Start Date : August 2006
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

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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.

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

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

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