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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 Endovenous Microfoam (PEM) 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 |
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| polidocanol injectable foam, 0.5% | Experimental |
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| polidocanol injectable foam, 1.0% | Experimental |
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| Vehicle | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polidocanol injectable foam, 0.125% | Drug | active placebo for blinding |
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| 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 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 VEINES QOL/Sym items that have been determined in earlier studies to be most important to patients. The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25). At Visit 2/baseline, Week 8, scores were calculated. | 8 weeks |
| 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 fo 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 |
|---|---|---|---|---|---|---|
| Dothan | Alabama | 36303 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26992303 | Derived | Todd KL 3rd, Wright DI; VANISH-2 Investigator Group. Durability of treatment effect with polidocanol endovenous microfoam on varicose vein symptoms and appearance (VANISH-2). J Vasc Surg Venous Lymphat Disord. 2015 Jul;3(3):258-264.e1. doi: 10.1016/j.jvsv.2015.03.003. Epub 2015 May 6. |
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Three (3) patients were randomized but never treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Vehicle: Injection of vehicle comparator |
| FG001 | Polidocanol Injectable Foam, 0.125% | active placebo for blinding of therapeutic polidocanol dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| polidocanol injectable foam, 0.5% | Drug | 0.5% polidocanol foam injection |
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| polidocanol injectable foam, 1.0% | Drug | 1.0% polidocanol foam injection |
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| Vehicle | Drug | injection of vehicle comparator |
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| 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 (0-4, where 0=none and 4=very severe visible varicose veins). | 8 weeks |
| San Diego |
| California |
| 92120 |
| United States |
| San Diego | California | 92121 | United States |
| Lafayette | Indiana | 47905 | United States |
| Frederick | Maryland | 21701 | United States |
| Hunt Valley | Maryland | 21030 | United States |
| Los Alamos | New Mexico | 87544 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Monroeville | Pennsylvania | 15143 | United States |
| Pittsburgh | Pennsylvania | 15232 | United States |
| Greenville | South Carolina | 29615 | United States |
| Bellevue | Washington | 98004 | United States |
| FG002 | Polidocanol Injectable Foam, 0.5% | lower experimental polidocanol dose |
| FG003 | Polidocanol Injectable Foam, 1.0% | 1.0% polidocanol foam injection |
| Patients Receiving Blinded Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Patients receiving blinded treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Vehicle: Injection of vehicle comparator |
| BG001 | Polidocanol Injectable Foam, 0.125% | polidocanol injectable foam active placebo |
| BG002 | Polidocanol Injectable Foam, 0.5% | polidocanol injectable foam lower experimental dose |
| BG003 | Polidocanol Injectable Foam, 1.0% | polidocanol injectable foam therapeutic dose |
| BG004 | 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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| Race/Ethnicity, Customized | Number | participants |
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| Weight | Mean | Standard Deviation | kilograms |
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| Height | Mean | Standard Deviation | centimeters |
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| Calculated BMI | Mean | Standard Deviation | kg/m^2 |
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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 | 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 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 VEINES QOL/Sym items that have been determined in earlier studies to be most important to patients. The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25). At Visit 2/baseline, Week 8, scores were calculated. | Number of subjects with a baseline value (VVSymQ) and value at the 8 week visit. | Posted | Least Squares Mean | Standard Error | units on a scale | 8 weeks |
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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 fo 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). | patients with a baseline and week 8 visit. | 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 (0-4, where 0=none and 4=very severe visible varicose veins). | Posted | Least Squares Mean | Standard Error | units on a scale | 8 weeks |
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Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)
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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 | Vehicle: Injection of vehicle comparator | 0 | 59 | 11 | 59 | ||
| EG001 | Polidocanol Injectable Foam, 0.125% | polidocanol injectable foam, 0.125% active placebo | 0 | 58 | 24 | 58 | ||
| EG002 | Polidocanol Injectable Foam, 0.5% | polidocanol injectable foam, 0.5% lower experimental dose | 0 | 60 | 27 | 60 | ||
| EG003 | Polidocanol Injectable Foam, 1.0% | polidocanol injectable foam target therapeutic dose | 0 | 58 | 47 | 58 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site thrombosis | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Venous thrombosis limb | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Hematoma | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Tenderness | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Wright MBBS | 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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| Black |
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| Asian |
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| American Indian/Eskimo |
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| Other |
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| ANCOVA |
| <0.0001 |
| Mean Difference (Final Values) |
| -4.00 |
| 2-Sided |
| 95 |
| -5.26 |
| -2.74 |
| Superiority or Other (legacy) |
| ANCOVA | <0.0001 | Mean Difference (Final Values) | -3.05 | 2-Sided | 95 | -4.33 | -1.77 | Superiority or Other (legacy) |
| OG003 | Polidocanol Injectable Foam, 1.0% | polidocanol injectable foam, experimental dose 1.0% |
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polidocanol injectable foam, 1.0% experimental dose |
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