CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 279 enrolled
Drug / intervention
Polidocanol injectable foam (PEM) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01072877
NCT01072877Phase 3Completed
CompareCT.gov

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

Boston Scientific Corporation·interventional·Posted Feb 22, 2010·Updated Apr 21, 2021

In Brief

A Phase 3 clinical trial evaluating Polidocanol injectable foam (PEM) and Placebo Vehicle for Varicose Veins. Completed, enrolled 279 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaricose Veins
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2010
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2011
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.4 years ago

Interventions

Polidocanol injectable foam (PEM)drug

Injection of Polidocanol injectable foam

Placebo Vehicledrug

Placebo vehicle