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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 concentrations of an investigational drug, polidocanol injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polidocanol injectable foam 0.125% | Experimental | Polidocanol injectable foam 0.125% |
|
| Polidocanol injectable foam 0.5% | Experimental | Polidocanol injectable foam 0.5% |
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| Polidocanol injectable foam 1.0% | Experimental | Polidocanol injectable foam 1.0% |
|
| Polidocanol injectable foam 2.0% | Experimental | Polidocanol injectable foam 2.0% |
|
| Vehicle | Placebo Comparator | Injection of vehicle comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polidocanol injectable foam (PEM) | Drug | Injection of Polidocanol injectable foam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) | The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level of activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching). The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity). At Visit 2/baseline, Week 8, scores were calculated | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laguna Hills | California | 92653 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26384639 | Derived | King JT, O'Byrne M, Vasquez M, Wright D; VANISH-1 Investigator Group. Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation Improves Symptoms and Appearance. Eur J Vasc Endovasc Surg. 2015 Dec;50(6):784-93. doi: 10.1016/j.ejvs.2015.06.111. Epub 2015 Sep 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Injection of vehicle comparator Placebo Vehicle: Placebo vehicle |
| FG001 | Polidocanol Endovenous Microfoam 0.125% | Polidocanol endovenous microfoam 0.125% Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo Vehicle | Drug | Placebo vehicle |
|
| 8 weeks |
| Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance | The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (where 0=none to 4=very severe visible varicose veins). | 8 weeks post treatment |
| San Diego |
| California |
| United States |
| Washington D.C. | District of Columbia | 20007 | United States |
| Aventura | Florida | 33180 | United States |
| Bradenton | Florida | 34209 | United States |
| Oakbrook Terrace | Illinois | 60181 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Kalamazoo | Michigan | 49009 | United States |
| Hartsdale | New York | 10530 | United States |
| New York | New York | 10016 | United States |
| North Tonawanda | New York | 14120 | United States |
| Stony Brook | New York | 10530 | United States |
| Charlotte | North Carolina | 28207 | United States |
| Durham | North Carolina | 27705 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Toledo | Ohio | 43606 | United States |
| Bend | Oregon | 97701 | United States |
| Clarksville | Tennessee | 37040 | United States |
| Kirkland | Washington | 98034 | United States |
| Spokane | Washington | 99204 | United States |
| FG002 | Polidocanol Endovenous Microfoam 0.5% | Polidocanol endovenous microfoam 0.5% Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam |
| FG003 | Polidocanol Endovenous Microfoam 1.0% | Polidocanol endovenous microfoam 1.0% Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam |
| FG004 | Polidocanol Endovenous Microfoam 2.0% | Polidocanol endovenous microfoam 2.0% Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam |
| COMPLETED |
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| NOT COMPLETED |
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Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Injection of vehicle comparator Placebo Vehicle: Placebo vehicle |
| BG001 | Polidocanol Injectable Foam 0.125% | Polidocanol injectable foam 0.125% |
| BG002 | Polidocanol Injectable Foam 0.5% | Polidocanol injectable foam 0.5% |
| BG003 | Polidocanol Injectable Foam 1.0% | Polidocanol injectable foam 1.0% |
| BG004 | Polidocanol Injectable Foam 2.0% | Polidocanol injectable foam2.0% |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) | The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level of activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching). The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity). At Visit 2/baseline, Week 8, scores were calculated | Posted | Mean | Standard Error | units on a scale | Week 8 |
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| Secondary | Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4). | Posted | Mean | Standard Error | units on a scale | 8 weeks |
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| Secondary | Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance | The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (where 0=none to 4=very severe visible varicose veins). | Population consists of all patients who had a baseline and on-treatment assessment. | Posted | Mean | Standard Error | units on a scale | 8 weeks post treatment |
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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 | Vehicle | Injection of vehicle Placebo Vehicle: Placebo vehicle | 0 | 56 | 20 | 56 | ||
| EG001 | Polidocanol Injectable Foam 0.125% | polidocanol injectable foam at a 0.125% concentration | 0 | 57 | 38 | 57 | ||
| EG002 | Polidcanol Injectable Foam 0.5% | polidocanol injectable foam at a 0.5% concentration | 0 | 51 | 46 | 51 | ||
| EG003 | Polidocanol Injectable Foam 1.0% | polidocanol injectable foam at a 1.0% concentration | 0 | 52 | 41 | 52 | ||
| EG004 | Polidocanol Endovenous Microfoam 2.0% | polidocanol injectable foam at a 2.0% concentration | 0 | 63 | 50 | 63 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Thrombophlebitis superficial | Vascular disorders | Systematic Assessment |
| ||
| Injection site hematoma | Vascular disorders | Systematic Assessment |
| ||
| Limb discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Venous thrombosis limb | Vascular disorders | Systematic Assessment |
| ||
| Injection site pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Infusion site thrombosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Edema peripheral | Vascular disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Extravasation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Wright MB FRCS | BTG International Inc | 610-278-1660 | 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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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Mean Difference (Final Values) |
| -3.54 |
| 2-Sided |
| 95 |
| -4.80 |
| -2.29 |
| Superiority or Other (legacy) |
| ANCOVA | <0.0001 | Mean Difference (Final Values) | -2.73 | 2-Sided | 95 | -3.98 | -1.48 | Superiority or Other (legacy) |
| ANCOVA | <0.0001 | Mean Difference (Final Values) | -3.65 | 2-Sided | 95 | -4.84 | -2.46 | Superiority or Other (legacy) |
| Polidocanol Injectable Foam 1.0% |
Polidocanol injectable foam at a 1.0% concentration |
| OG004 | Polidocanol Injectable Foam 2.0% | Polidocanol injectable foam at a 2.0% concentration |
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|
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| OG003 |
| Polidocanol Injectable Foam 1.0% |
Polidocanol injectable foam at a 1.0% concentration |
| OG004 | Polidocanol Injectable Foam 2.0% | Polidocanol injectable foam at a 2.0% concentration |
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