drugset / Trial / NCT01231373

Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

NCT01231373

Phase 3 Completed 235 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 Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Timeline

Start
2010-11
Primary completion
2011-09
Completion
2014-08

Drugs

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

Indications