NCT01428076

Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)

An Open-Label Single-Center Study in Patients With Great Saphenous Vein Incompetence to Investigate the Pharmacokinetic Properties of Polidocanol Endovenous Microfoam (PEM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (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 pharmacokinetic profile of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM), an investigational treatment for varicose veins.

Conditions

• Varicose Veins

Interventions

Type	Name	Description
DRUG	Polidocanol Endovenous Microfoam (PEM)	Pharmacokinetic comparison of different doses of drug

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-09-02
• Last updated: 2021-04-21
• Results posted: 2014-03-31

Locations

1 site across 1 country: United States