Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Endovenous Microfoam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence - Full Text View

Sponsor:	BTG International Inc.
Information provided by:	BTG International Inc.
ClinicalTrials.gov Identifier:	NCT00758420

Purpose

The purpose of this study is to evaluate the effectiveness of Varisolve 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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Single Blind, Placebo Controlled, Multicenter Study to Evaluate Efficacy and Safety of Varisolve (Polidoncanol Endovenous Microfoam) for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence.

Resource links provided by NLM:

MedlinePlus related topics: Varicose Veins

U.S. FDA Resources

Further study details as provided by BTG International Inc.:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	74
Study Start Date:	October 2008
Study Completion Date:	September 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Varisolve (polidocanol endovenous mircofoam)	Drug: Varisolve (Polidocanol Endovenous Microfoam) 1% polidocanol, up to 15 mL, one treatment session
2: Placebo Comparator 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 Varisolve vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of an 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 Varisolve 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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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 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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Study Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	BTG International Inc ( VP of Clinical Development )
Study ID Numbers:	VAP.VV013
Study First Received:	September 22, 2008
Last Updated:	November 24, 2009
ClinicalTrials.gov Identifier:	NCT00758420 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by BTG International Inc.:

Varicose Veins

Additional relevant MeSH terms:

Varicose Veins
Therapeutic Uses
Vascular Diseases
Polidocanol

Sclerosing Solutions
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010