Efficacy and Safety Study of Varisolve™ Polidocanol Endovenous Microfoam (PEM)for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc. ( BTG Ltd. )
ClinicalTrials.gov Identifier:
NCT01072877
First received: February 19, 2010
Last updated: December 9, 2013
Last verified: December 2013

February 19, 2010
December 9, 2013
November 2010
April 2012   (final data collection date for primary outcome measure)
Change in patient-reported symptoms of varicose veins [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
The absolute change from Baseline in symptom score.
The absolute change from baseline for the VVSymQ. An analysis of the absolute change from baseline using the patient's daily self-assessment of varicose vein pain will be conducted in support of the symptoms endpoint. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01072877 on ClinicalTrials.gov Archive Site
Change in appearance as rated by patient and central independent photography review [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The abolsute change form Baseline in appearance score.
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety Study of Varisolve™ Polidocanol Endovenous Microfoam (PEM)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%, 1.0%, or 2.0% Compared to Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

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: Polidocanol Endovenous Microfoam (PEM)
    Injection of Polidocanol Endovenous Microfoam
    Other Name: PEM
  • Drug: Placebo Vehicle
    Placebo vehicle
    Other Name: Placebo vehicle
  • Experimental: Polidocanol endovenous microfoam 0.125%
    Polidocanol endovenous microfoam 0.125%
    Intervention: Drug: Polidocanol Endovenous Microfoam (PEM)
  • Experimental: Polidocanol endovenous microfoam 0.5%
    Polidocanol endovenous microfoam 0.5%
    Intervention: Drug: Polidocanol Endovenous Microfoam (PEM)
  • Experimental: Polidocanol endovenous microfoam 1.0%
    Polidocanol endovenous microfoam 1.0%
    Intervention: Drug: Polidocanol Endovenous Microfoam (PEM)
  • Experimental: Polidocanol endovenous microfoam 2.0%
    Polidocanol endovenous microfoam 2.0%
    Intervention: Drug: Polidocanol Endovenous Microfoam (PEM)
  • Placebo Comparator: Vehicle
    Injection of vehicle comparator
    Intervention: Drug: Placebo Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
December 2012
April 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 (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
  • 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
 
NCT01072877
VAP.VV015
Yes
BTG International Inc. ( BTG Ltd. )
BTG Ltd.
Not Provided
Not Provided
BTG International Inc.
December 2013

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