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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

August 30, 2011
April 4, 2014
August 2011
February 2012   (final data collection date for primary outcome measure)
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
Profile of pharmacokinetics [ Time Frame: 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, Area Under Curve, Tmax
Complete list of historical versions of study NCT01428076 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Varicose Veins
Drug: Polidocanol Endovenous Microfoam (PEM)
Pharmacokinetic comparison of different doses of drug
  • Experimental: High Dose Polidocanol Endovenous Microfoam
    Intervention: Drug: Polidocanol Endovenous Microfoam (PEM)
  • Experimental: Medium Dose Polidocanol Endovenous Microfoam
    Intervention: Drug: Polidocanol Endovenous Microfoam (PEM)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
August 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01428076
VAP.VV008
No
BTG International Inc.
BTG International Inc.
Not Provided
Not Provided
BTG International Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP