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
  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 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.


Condition Intervention Phase
Varicose Veins
Drug: Vehicle
Drug: polidocanol injectable foam, 1.0%
Drug: polidocanol injectable foam, 0.125%
Drug: polidocanol injectable foam, 0.5%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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"

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 235
Study Start Date: November 2010
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: polidocanol injectable foam, 1.0% Drug: polidocanol injectable foam, 1.0%
1.0% polidocanol foam injection
Experimental: polidocanol injectable foam, 0.125% Drug: polidocanol injectable foam, 0.125%
active placebo for blinding
Placebo Comparator: Vehicle Drug: Vehicle
Injection of vehicle comparator
Experimental: polidocanol injectable foam, 0.5%
polidocanol injectable foam, 0.5%
Drug: polidocanol injectable foam, 0.5%
polidocanol injectable foam, 0.5% (low dose)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01231373

Locations
United States, Alabama
Dothan, Alabama, United States, 36303
United States, California
San Diego, California, United States, 92121
San Diego, California, United States, 92120
United States, Indiana
Lafayette, Indiana, United States, 47905
United States, Maryland
Frederick, Maryland, United States, 21701
Hunt Valley, Maryland, United States, 21030
United States, New Mexico
Los Alamos, New Mexico, United States, 87544
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Monroeville, Pennsylvania, United States, 15143
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Greenville, South Carolina, United States, 29615
United States, Washington
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
BTG International Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01231373     History of Changes
Other Study ID Numbers: VAP.VV016
Study First Received: October 22, 2010
Results First Received: December 20, 2013
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by BTG International Inc.:
varicose veins

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

ClinicalTrials.gov processed this record on October 23, 2014