Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01428076
First received: August 30, 2011
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Varicose Veins
Drug: Polidocanol Endovenous Microfoam (PEM)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Weight-adjusted Polidocanol Cmax (Serum) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Cmax measured and adjusted for weight


Enrollment: 21
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Dose Polidocanol Endovenous Microfoam Drug: Polidocanol Endovenous Microfoam (PEM)
Pharmacokinetic comparison of different doses of drug
Experimental: Medium Dose Polidocanol Endovenous Microfoam Drug: Polidocanol Endovenous Microfoam (PEM)
Pharmacokinetic comparison of different doses of drug

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428076

Locations
United States, Florida
Cardiovascular and Vein Center of Florida
Bradenton, Florida, United States, 34209
Sponsors and Collaborators
BTG International Inc.
  More Information

No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01428076     History of Changes
Other Study ID Numbers: VAP.VV008
Study First Received: August 30, 2011
Results First Received: January 15, 2014
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by BTG International Inc.:
Varicose Veins
SFJ Reflux

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 28, 2014