Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Endovenous Microfoam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence (Pilot)
This study has been completed.
Sponsor:
BTG Ltd.
Information provided by (Responsible Party):
BTG Ltd.
ClinicalTrials.gov Identifier:
NCT00758420
First received: September 22, 2008
Last updated: September 21, 2011
Last verified: September 2011
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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
Drug Information available for:
Polidocanol
U.S. FDA Resources
Further study details as provided by BTG Ltd.:
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 ]
| Enrollment: | 77 |
| 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 |
|---|---|
|
Active Comparator: 1
Varisolve (polidocanol endovenous mircofoam)
|
Drug: Varisolve (Polidocanol Endovenous Microfoam)
1% polidocanol, up to 15 mL, one treatment session
|
|
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 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 Ltd.
Investigators
| Study Chair: | Janet Rush, MD | BTG Ltd. |
More Information
Additional Information:
No publications provided
| Responsible Party: | BTG Ltd. |
| ClinicalTrials.gov Identifier: | NCT00758420 History of Changes |
| Other Study ID Numbers: | VAP.VV013 |
| Study First Received: | September 22, 2008 |
| Last Updated: | September 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by BTG Ltd.:
|
Varicose Veins |
Additional relevant MeSH terms:
|
Varicose Veins Vascular Diseases Cardiovascular Diseases Polidocanol |
Sclerosing Solutions Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013