Back to resultsALF-STONE: Alfuzosin in Uretheric Stones
Primary Purpose
Prostatic Hyperplasia
Status
Terminated
Phase
Phase 3
Locations
Portugal
Study Type
Interventional
Intervention
Alfuzosin
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
Safety: General clinical safety by collection of spontaneously reported adverse events
Efficacy: Percentage of patients without imagiologic evidence of any stone
Secondary Outcome Measures
Percentage of patients without imagiologic evidence of any stone
Percentage of patients with clinical evidence of stones clearance
Time for stone clearance (clinical evaluation)
Numeric Rating Scale scores
Need for rescue analgesic medication.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00454402
Brief Title
ALF-STONE: Alfuzosin in Uretheric Stones
Official Title
Alfuzosin in Uretheric Stones
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Terminated
Why Stopped
Discontinued due to incomplete recruitment
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Primary Outcome Measure Information:
Title
Safety: General clinical safety by collection of spontaneously reported adverse events
Time Frame
at each visit
Title
Efficacy: Percentage of patients without imagiologic evidence of any stone
Time Frame
72h to 96 hours after ESWL
Secondary Outcome Measure Information:
Title
Percentage of patients without imagiologic evidence of any stone
Time Frame
24 hours after ESWL
Title
Percentage of patients with clinical evidence of stones clearance
Time Frame
72h to 96 hours after ESWL
Title
Time for stone clearance (clinical evaluation)
Title
Numeric Rating Scale scores
Time Frame
at 24h, (48h, if applicable), 72-96h and 7 days
Title
Need for rescue analgesic medication.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Santos, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Lisbon
Country
Portugal
12. IPD Sharing Statement
Learn more about this trial
ALF-STONE: Alfuzosin in Uretheric Stones
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