Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01231373
First received: October 22, 2010
Last updated: February 19, 2014
Last verified: February 2014

October 22, 2010
February 19, 2014
November 2010
January 2012   (final data collection date for primary outcome measure)
The Absolute Change From Baseline in Patient Symptom Assessment Score (Called VVSymQ). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
20 questions about varicose vein symptoms, and 5 prespecified most clinically relevant symptoms formulated as questions contributed to the VVSymQ score. 5 items measured on a six-point duration scale, 0 (none of the time) to 25 (all of the time), and added together to generate a score ranging from 0 to 25. Scores averaged over 7 most recent days prior to study visit, min of 4 daily reports required ot calculate avg VVSymQ. Absolute change in scores from baseline to week 8 were compared between vehicle and each dose.
Change in patient-reported symptoms of varicose veins [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The absolute change from Baseline in symptom score.
Complete list of historical versions of study NCT01231373 on ClinicalTrials.gov Archive Site
  • Change in Varicose Vein Appearance as Rated by Blinded Central Independent Physician Photography Review [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The absolute change from baseline in appearance score blinded independent photography review (IPR-V3; physician appearance assessment) at week 8. Panel of 3 blinded physicians reviewed before/after standardized digital photos and provided scores ranging from 0 (no varicose veins visible) to 4 (very severe). Scores were averaged by reviewer. Absolute change in scores from baseline to week 8 were compared between vehicle and each dose.
  • Absolute Change From Baseline to Week 8 (PA-V3; Patient Assessment of Varicose Vein Appearance) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Patient-based assessment of change in varicose vein appearance based on PA-V3 scale. Patient assessment of before/after images of varicose veins, scoring from 0 (not at all noticeable) to 4 (extremely noticeable). Scores averaged per patient. Absolute change in scores from baseline to week 8 were compared between vehicle and each dose.
Change in appearance as rated by patient and central independent photography review [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The absolute change from Baseline in appearance score
Not Provided
Not Provided
 
Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Varisolve Polidocanol Endovenous Microfoam (PEM) 0.5% and 1% Compared to Vehicle for the Treatment on Saphenofemoral Junction (SFJ) Incompetence "VANISH-2"

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 safety and effectiveness of three different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Varicose Veins
  • Drug: Vehicle
    Injection of vehicle comparator
  • Drug: polidocanol injectable foam, 1.0%
    1.0% polidocanol foam injection
  • Drug: polidocanol injectable foam, 0.125%
    active placebo for blinding
  • Drug: polidocanol injectable foam, 0.5%
    polidocanol injectable foam, 0.5% (low dose)
  • Experimental: polidocanol injectable foam, 1.0%
    Intervention: Drug: polidocanol injectable foam, 1.0%
  • Experimental: polidocanol injectable foam, 0.125%
    Intervention: Drug: polidocanol injectable foam, 0.125%
  • Placebo Comparator: Vehicle
    Intervention: Drug: Vehicle
  • Experimental: polidocanol injectable foam, 0.5%
    polidocanol injectable foam, 0.5%
    Intervention: Drug: polidocanol injectable foam, 0.5%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
235
June 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Incompetence of SFJ
  • Ability to comprehend and sign an informed consent document and complete study questionnaires in English
  • Ability to record symptoms in accordance with the protocol
  • Symptomatic varicose veins
  • Visible varicose veins

Exclusion Criteria:

  • 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
  • Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
  • Reduced mobility
  • Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
  • 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.)
  • 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01231373
VAP.VV016
Yes
BTG International Inc.
BTG International Inc.
Not Provided
Not Provided
BTG International Inc.
February 2014

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