drugset / Trial / NCT01072877

Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

NCT01072877

Phase 3 Completed 279 enrolled Boston Scientific Corporation
RandomizedParallel-groupDouble-blindTreatment

Summary

Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, polidocanol injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Timeline

Start
2010-12
Primary completion
2011-12
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Polidocanol Other / unclassified 0.125 % Other
Subject Polidocanol Other / unclassified 0.5 % Other
Subject Polidocanol Other / unclassified 1 % Other
Subject Polidocanol Other / unclassified 2 % Other

Indications