NCT01072877

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

A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Polidocanol Injectable Foam 0.5%, 1.0%, or 2.0% Compared to Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Varicose Veins

Interventions

Type	Name	Description
DRUG	Polidocanol injectable foam (PEM)	Injection of Polidocanol injectable foam
DRUG	Placebo Vehicle	Placebo vehicle

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-12-01
• Completion: 2012-11-01
• First posted: 2010-02-22
• Last updated: 2021-04-21
• Results posted: 2014-05-16

Locations

20 sites across 1 country: United States