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...
Date First Received: March 29, 2007
Last Updated: September 21, 2007
Verified by: Sanofi-Aventis, September 2007
Clinical Trial Phase: Phase 3 | Start Date: August 2006
Overall Status: Terminated
Estimated Enrollment: 220
Brief Summary
Official Title: “Alfuzosin in Uretheric Stones”
Condition Keyword(s):
Intervention(s):
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).
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Alfuzosin
Outcome Measures for this Clinical Trial
Primary Measures
- Safety: General clinical safety by collection of spontaneously reported adverse events
- Time Frame: at each visit
- Time Frame: at each visit
- Efficacy: Percentage of patients without imagiologic evidence of any stone
- Time Frame: 72h to 96 hours after ESWL
- Time Frame: 72h to 96 hours after ESWL
Secondary Measures
- Percentage of patients without imagiologic evidence of any stone
- Time Frame: 24 hours after ESWL
- Time Frame: 24 hours after ESWL
- Percentage of patients with clinical evidence of stones clearance
- Time Frame: 72h to 96 hours after ESWL
- 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
- Time Frame: at 24h, (48h, if applicable), 72-96h and 7 days
- Need for rescue analgesic medication.
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Sanofi-Aventis
Overall Clinical Trial Officials and Contacts
Carlos Santos, MD Study Director Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00454402
Study ID Number: L_9795
ClinicalTrials.gov Identifier: NCT00454402
Health Authority: Portugal: National Pharmacy and Medicines Institute
Clinical Trials Authorship and Review
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