ALF-STONE: Alfuzosin in Uretheric Stones

• Sponsor: Sanofi (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00454402
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 20

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Drug: Alfuzosin	Phase 3

Study Design

• Study Type: Interventional
• Anticipated 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: Aug 1, 2006
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. Safety: General clinical safety by collection of spontaneously reported adverse events [at each visit]

2. Efficacy: Percentage of patients without imagiologic evidence of any stone [72h to 96 hours after ESWL]

Secondary Outcome Measures

1. Percentage of patients without imagiologic evidence of any stone [24 hours after ESWL]

2. Percentage of patients with clinical evidence of stones clearance [72h to 96 hours after ESWL]

3. Time for stone clearance (clinical evaluation) []

4. Numeric Rating Scale scores [at 24h, (48h, if applicable), 72-96h and 7 days]

5. Need for rescue analgesic medication. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Lisbon		Portugal

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Carlos Santos, MD, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00454402
• Other Study ID Numbers: L_9795; EudraCT # : 2005-005481-36
• First Posted: Mar 30, 2007
• Last Update Posted: Sep 24, 2007
• Last Verified: Sep 1, 2007

• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Alfuzosin

Study Results

No Results Posted as of Sep 24, 2007