Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT00758420
First received: September 22, 2008
Last updated: February 19, 2015
Last verified: February 2015

September 22, 2008
February 19, 2015
October 2008
July 2009   (final data collection date for primary outcome measure)
The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
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.
The absolute change from baseline score for the VEINES-Sym questionnaire (overall score) at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00758420 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence
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.
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Varicose Veins
  • 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)
  • Drug: Agitated Saline
    10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
  • Active Comparator: 1
    Varisolve (polidocanol endovenous mircofoam)
    Intervention: Drug: Varisolve (Polidocanol Endovenous Microfoam)
  • Placebo Comparator: 2
    Agitated saline
    Intervention: Drug: Agitated Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
August 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00758420
VAP.VV013
No
Not Provided
Not Provided
BTG International Inc.
BTG International Inc.
Not Provided
Study Chair: Janet Rush, MD BTG International Inc.
BTG International Inc.
February 2015

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