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Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence (Pilot)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758420
First Posted: September 25, 2008
Last Update Posted: March 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
BTG International Inc.
  Purpose
The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.

Condition Intervention Phase
Varicose Veins Drug: Varisolve (Polidocanol Endovenous Microfoam) Drug: Agitated Saline Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Single Blind, Placebo Controlled, Multicenter Study to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence.

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks [ Time Frame: Baseline to 8 weeks ]
    The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = [(Raw Score) - 5] * 4.


Enrollment: 77
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Varisolve (polidocanol endovenous mircofoam)
Drug: Varisolve (Polidocanol Endovenous Microfoam)
1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2)
Placebo Comparator: 2
Agitated saline
Drug: Agitated Saline
10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session

Detailed Description:
The purpose of this study is to evaluate the efficacy of polidocanol injectable foam vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of a minimally important difference (MID) for the questionnaires, improvement in the appearance of visible varicosities by a patient and medical assessments aided by pre and post treatment photographs, and a central independent assessor evaluating pre and post treatment photographs. In addition, the study will evaluate the efficacy of polidocanol injectable foam vs the placebo treatment in the elimination of SFJ reflux or occlusion of the treated vein, and to determine whether the placebo procedure blinds the patient to treatment assignment.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and Females 18-65 years old
  • VEINES Sym Score less than 75 points
  • Varicose Vein clinical classification CEAP 2, 3, 4, or 5
  • Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
  • Superficial venous disease manifested by both symptoms and visible varicosities
  • Ability to comprehend and sign an informed consent document and completed study questionnaires in English

Exclusion Criteria:

  • Incompetence of the SSV which substantially contributes to the filling of visible varicose veins
  • Current or previous Deep Vein Thrombosis
  • Leg obesity
  • Peripheral arterial disease in the leg to be treated
  • Reduced mobility
  • Planned prolonged travel with limited mobility with in 4 weeks of treatment
  • History of pulmonary embolism or stroke
  • Major surgery, prolonged hospitalization or pregnancy within 3 months
  • Current anticoagulation therapy (within 7 days of enrollment)
  • Participation in a clinical study involving a investigational product within 3 months
  • Major co-existing disease or clinically significant laboratory abnormalities
  • Known allergic response to polidocanol or heparin or severe and/or multiple allergic reactions
  • Women of childbearing potential not using effective contraception one month prior to enrollment and/or unwilling to continue while on study
  • Pregnant or lactating women
  • Current alcohol or drug abuse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758420


Locations
United States, Arizona
Scottsdale, Arizona, United States, 85255
United States, New York
New York, New York, United States, 10016
United States, North Carolina
Charlotte, North Carolina, United States, 28207
Winston Salem, North Carolina, United States, 27157
United States, Washington
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
BTG International Inc.
Investigators
Study Chair: Janet Rush, MD BTG International Inc.
  More Information

Additional Information:
Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00758420     History of Changes
Other Study ID Numbers: VAP.VV013
First Submitted: September 22, 2008
First Posted: September 25, 2008
Results First Submitted: January 6, 2014
Results First Posted: March 24, 2014
Last Update Posted: March 9, 2015
Last Verified: February 2015

Keywords provided by BTG International Inc.:
Varicose Veins

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions


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