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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Varisolve (polidocanol endovenous mircofoam) |
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| 2 | Placebo Comparator | Agitated saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varisolve (Polidocanol Endovenous Microfoam) | Drug | 1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 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. | Baseline to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Rush, MD | BTG International Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85255 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27013511 | Derived | Gibson K, Kabnick L; Varithena(R) 013 Investigator Group. A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena(R) (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence. Phlebology. 2017 Apr;32(3):185-193. doi: 10.1177/0268355516635386. Epub 2016 Jul 9. |
| Label | URL |
|---|---|
| Study Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | polidocanol injectiable foam 1%, up to 15 mL, one treatment session |
| FG001 | Placebo | Agitated saline Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Agitated Saline | Drug | 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session |
|
| New York |
| New York |
| 10016 |
| United States |
| Charlotte | North Carolina | 28207 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Bellevue | Washington | 98004 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Treated patients with a week 8 study assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session |
| BG001 | Polidocanol Injectable Foam, 1.0% | Polidocanol injectable foam 1%, up to 15 mL, one treatment session |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Baseline VCSS | The Venous Clinical Severity Score (VCSS) was determined by a study staff member blinded to treatment assignment, (i.e., the 'blinded assessor'). The VCSS rates 9 clinical characteristics of chronic venous disease (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, and number, duration, and size of ulcers) using Grades 0 to 3 (absent to severe). An additional 0 to 3 points are added for differences in use of compression therapy (compression and elevation) to produce a 30-point maximum flat scale. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| CEAP Clinical classification | Patients were eligible for study if they had a clinical classification of C2-C5 as follows: C2 Varicose veins C3 Edema C4 Skin changes without ulceration C5 Skin changes with healed ulceration. | Number | participants |
| |||||||||||||||
| VVSymQ Score | 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 | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| VEINES-Sym Score | The VEINES-Sym summary score includes 10 items; 9 venous symptoms (heavy legs, aching legs, swelling, night cramps, heat or burning sensation, restless legs, throbbing, itching, tingling sensation), rated on a 6-point scale of frequency and leg pain rated on a 6-point scale of intensity (very severe, severe, moderate, mild, very mild, none). It can range from 0 to 100, with a '0' score indicating all symptoms were present all of the time in the past week and a '100' score indicating none of the symptoms were present at any time in the previous week. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to 8 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | agitated saline | 1 | 38 | 19 | 38 | ||
| EG001 | Polidocanol Injectable Foam, 1.0% | polidocanol injectable foam 1%, up to 15 mL, one treatment session | 1 | 39 | 36 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient ischemic attack | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Sick sinus syndrome | Cardiac disorders | MedDRA 13.1 | Systematic Assessment | unrelated to study drug. resulted from pacemaker placement. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chest discomfort | General disorders | Systematic Assessment |
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| edema | General disorders | Systematic Assessment |
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| nasopharyngitis | Infections and infestations | Systematic Assessment |
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| contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| incision site complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| incision site hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| limb discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| headache | Nervous system disorders | Systematic Assessment |
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| paresthesia | Nervous system disorders | Systematic Assessment |
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| pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| hematoma evacuation | Surgical and medical procedures | Systematic Assessment |
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| thrombectomy | Surgical and medical procedures | Systematic Assessment |
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| deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| venous thrombosis | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Wright MBBS | BTG International Inc. | 610-943-3538 | david.wright@btgplc.com |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| C4 - Skin Change Without Ulceration |
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| C5 - Skin Change With Healed Ulceration |
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