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Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01428076
Recruitment Status : Completed
First Posted : September 2, 2011
Results First Posted : March 31, 2014
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Varicose Veins Drug: Polidocanol Endovenous Microfoam (PEM) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : August 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins
Drug Information available for: Polidocanol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    Cmax measured and adjusted for weight


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428076


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

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01428076     History of Changes
Other Study ID Numbers: VAP.VV008
First Posted: September 2, 2011    Key Record Dates
Results First Posted: March 31, 2014
Last Update Posted: March 6, 2015
Last Verified: February 2015

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

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions