Clinical trial NCT01428076: Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)
Official title: An Open-Label Single-Center Study in Patients With Great Saphenous Vein Incompetence to Investigate the Pharmacokinetic Properties of Polidocanol Endovenous Microfoam (PEM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Varicose Veins
Keywords: Varicose Veins
SFJ Reflux
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: BTG International Inc.
First posted: 2011-09-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male or female; age 18 to 75 years
* Superficial venous disease where SFJ incompetence is the predominant source of reflux (reflux \> 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein
* Expected need for microfoam of 10 mL to fill the incompetent GSV and tributaries (minimum trunk vein diameter of 6mm)
* Clinically normal renal and hepatic function on serum chemistry
* Ability to comprehend and sign an informed consent document in English

Exclusion Criteria:

* Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
* Clinically significant abnormal ECG or clinical condition which may affect interpretation of ECG, for example, history of Long QT Syndrome, Brugada Syndrome, electronic cardiac pacemaker, chronic atrial fibrillation, recent myocardial infarction or congestive heart failure.
* Patients taking QT prolonging medications
* Any of the following findings on screening ECG:
* QRS \> 110 ms
* HR \< 45 bpm
* HR \> 100 bpm
* QTcF \> 470 ms
* PR \> 220 ms
* Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders)
* Leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure compression bandaging and stockings
* Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
* Deep venous reflux unless clinically insignificant in comparison to superficial reflux
* Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
* Reduced mobility (unable to walk unaided for 5 minutes per waking hour)
* History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior DVT on duplex ultrasound
* Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
* Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions
* Current alcohol or drug abuse
* Pregnant or lactating women
* Women of childbearing potential not using effective contraception for at least one month prior to study enrollment (i.e., treatment) and/or unwilling to continue birth control until Visit 4
* Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening
* Previous treatment with Polidocanol Endovenous Microfoam (PEM) in a previous PEM study

Primary outcomes:
measure: Weight-adjusted Polidocanol Cmax (Serum)
timeFrame: pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Cardiovascular and Vein Center of Florida
state: Florida
Study officials:
References: