Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01072877
First received: February 19, 2010
Last updated: April 15, 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 safety and effectiveness of three different concentrations of an investigational drug, polidocanol injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.


Condition Intervention Phase
Varicose Veins
Drug: Polidocanol injectable foam (PEM)
Drug: Placebo Vehicle
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 Polidocanol Injectable Foam 0.5%, 1.0%, or 2.0% Compared to Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level of activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching.

    The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity).

    At Visit 2/baseline, Week 8, scores were calculated



Secondary Outcome Measures:
  • Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4).

  • Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance [ Time Frame: 8 weeks post treatment ] [ Designated as safety issue: No ]
    The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 8 trained, blinded clinicians evaluated the appearance of the patient's visible varicose veins using thre IPR-V3 instrument's 5-point scale (where 0=none to 5=very severe visible varicose veins).


Enrollment: 279
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Polidocanol injectable foam 0.125%
Polidocanol injectable foam 0.125%
Drug: Polidocanol injectable foam (PEM)
Injection of Polidocanol injectable foam
Experimental: Polidocanol injectable foam 0.5%
Polidocanol injectable foam 0.5%
Drug: Polidocanol injectable foam (PEM)
Injection of Polidocanol injectable foam
Experimental: Polidocanol injectable foam 1.0%
Polidocanol injectable foam 1.0%
Drug: Polidocanol injectable foam (PEM)
Injection of Polidocanol injectable foam
Experimental: Polidocanol injectable foam 2.0%
Polidocanol injectable foam 2.0%
Drug: Polidocanol injectable foam (PEM)
Injection of Polidocanol injectable foam
Placebo Comparator: Vehicle
Injection of vehicle comparator
Drug: Placebo Vehicle
Placebo vehicle
Other Name: Placebo vehicle

  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 associated with incompetence of the GSV or other major accessory vein
  • 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 (clinical, etiologic, anatomic, and pathophysiologic) Classification of Venous Disorders).
  • Leg obesity impairing the ability to access the vein to be treated and/or to apply postprocedure compression bandaging and stockings
  • Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
  • Deep vein reflux unless clinically insignificant in comparison to superficial reflux
  • 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
  • History of DVT, pulmonary embolism or stroke
  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: NCT01072877

Locations
United States, California
Laguna Hills, California, United States, 92653
San Diego, California, United States
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Aventura, Florida, United States, 33180
Bradenton, Florida, United States, 34209
United States, Illinois
Oakbrook Terrace, Illinois, United States, 60181
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Kalamazoo, Michigan, United States, 49009
United States, New York
Hartsdale, New York, United States, 10530
New York, New York, United States, 10016
North Towanda, New York, United States, 14120
Stony Brook, New York, United States, 10530
United States, North Carolina
Charlotte, North Carolina, United States, 28207
Durham, North Carolina, United States, 27705
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Toledo, Ohio, United States, 43606
United States, Oregon
Bend, Oregon, United States, 97701
United States, Tennessee
Clarksville, Tennessee, United States, 37040
United States, Washington
Kirkland, Washington, United States, 98034
Spokane, Washington, United States, 99204
Sponsors and Collaborators
BTG International Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01072877     History of Changes
Other Study ID Numbers: VAP.VV015
Study First Received: February 19, 2010
Results First Received: January 15, 2014
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by BTG International Inc.:
Varicose Veins

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 September 14, 2014