At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
Polidocanol Endovenous Microfoam (PEM)drug
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.
An Open-Label Single-Center Study in Patients With Great Saphenous Vein Incompetence to Investigate the Pharmacokinetic Properties of Polidocanol Endovenous Microfoam (PEM)
In Brief
A Phase 1 clinical trial evaluating Polidocanol Endovenous Microfoam (PEM) for Varicose Veins. Completed, enrolled 21 participants across 1 site.
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 pharmacokinetic profile of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM), an investigational treatment for varicose veins.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaricose Veins
CountriesUnited States
CollaboratorsBTG International Inc.
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2011
First PostedSep 2011
Primary CompletionJan 2012
TodayJul 2026
First PostedSep 2, 2011
Enrollment StartAug 1, 2011
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.8 years ago
Interventions
Polidocanol Endovenous Microfoam (PEM)drug
Pharmacokinetic comparison of different doses of drug