Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-2)
This study has been completed.
Sponsor:
BTG Ltd.
Information provided by (Responsible Party):
BTG Ltd.
ClinicalTrials.gov Identifier:
NCT01231373
First received: October 22, 2010
Last updated: March 7, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Varicose Veins Saphenofemoral Junction (SFJ) Incompetence |
Drug: Vehicle comparator Drug: High dose Polidocanol endovenous microfoam Drug: Mid dose Polidocanol endovenous microfoam Drug: Low dose Polidocanol endovenous microfoam |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Varisolve Polidocanol Endovenous Microfoam (PEM) 0.5% and 1% Compared to Vehicle for the Treatment on Saphenofemoral Junction (SFJ) Incompetence "VANISH-2" |
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:
- Change in patient-reported symptoms of varicose veins [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The absolute change from Baseline in symptom score.
Secondary Outcome Measures:
- Change in appearance as rated by patient and central independent photography review [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The absolute change from Baseline in appearance score
| Enrollment: | 228 |
| Study Start Date: | November 2010 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PEM high dose |
Drug: High dose Polidocanol endovenous microfoam
Injection of high dose PEM
|
| Experimental: PEM mid dose |
Drug: Mid dose Polidocanol endovenous microfoam
Injection of mid dose PEM
|
| Experimental: PEM low dose |
Drug: Low dose Polidocanol endovenous microfoam
Injection of low dose PEM
|
| Placebo Comparator: Vehicle |
Drug: Vehicle comparator
Injection of vehicle comparator
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 Classification of Venous Disorders).
- Leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231373
Locations
| United States, Alabama | |
| Dothan, Alabama, United States, 36303 | |
| United States, California | |
| San Diego, California, United States, 92121 | |
| San Diego, California, United States, 92120 | |
| United States, Indiana | |
| Lafayette, Indiana, United States, 47905 | |
| United States, Maryland | |
| Frederick, Maryland, United States, 21701 | |
| Hunt Valley, Maryland, United States, 21030 | |
| United States, New Mexico | |
| Los Alamos, New Mexico, United States, 87544 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Monroeville, Pennsylvania, United States, 15143 | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, South Carolina | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Washington | |
| Bellevue, Washington, United States, 98004 | |
Sponsors and Collaborators
BTG Ltd.
More Information
Additional Information:
No publications provided
| Responsible Party: | BTG Ltd. |
| ClinicalTrials.gov Identifier: | NCT01231373 History of Changes |
| Other Study ID Numbers: | VAP.VV016 |
| Study First Received: | October 22, 2010 |
| Last Updated: | March 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by BTG Ltd.:
|
varicose veins varicosities SFJ incompetence |
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 22, 2013