Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01072877
First received: February 19, 2010
Last updated: April 15, 2014
Last verified: April 2014
Results First Received: January 15, 2014  
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
Condition: Varicose Veins
Interventions: Drug: Polidocanol injectable foam (PEM)
Drug: Placebo Vehicle

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vehicle

Injection of vehicle comparator

Placebo Vehicle: Placebo vehicle

Polidocanol Endovenous Microfoam 0.125%

Polidocanol endovenous microfoam 0.125%

Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam

Polidocanol Endovenous Microfoam 0.5%

Polidocanol endovenous microfoam 0.5%

Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam

Polidocanol Endovenous Microfoam 1.0%

Polidocanol endovenous microfoam 1.0%

Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam

Polidocanol Endovenous Microfoam 2.0%

Polidocanol endovenous microfoam 2.0%

Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam


Participant Flow:   Overall Study
    Vehicle     Polidocanol Endovenous Microfoam 0.125%     Polidocanol Endovenous Microfoam 0.5%     Polidocanol Endovenous Microfoam 1.0%     Polidocanol Endovenous Microfoam 2.0%  
STARTED     56     57     51     52     63  
COMPLETED     55     56     51     50     63  
NOT COMPLETED     1     1     0     2     0  
Lost to Follow-up                 1                 1                 0                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population

Reporting Groups
  Description
Vehicle

Injection of vehicle comparator

Placebo Vehicle: Placebo vehicle

Polidocanol Injectable Foam 0.125% Polidocanol injectable foam 0.125%
Polidocanol Injectable Foam 0.5% Polidocanol injectable foam 0.5%
Polidocanol Injectable Foam 1.0% Polidocanol injectable foam 1.0%
Polidocanol Injectable Foam 2.0% Polidocanol injectable foam2.0%
Total Total of all reporting groups

Baseline Measures
    Vehicle     Polidocanol Injectable Foam 0.125%     Polidocanol Injectable Foam 0.5%     Polidocanol Injectable Foam 1.0%     Polidocanol Injectable Foam 2.0%     Total  
Number of Participants  
[units: participants]
  56     57     51     52     63     279  
Age  
[units: years]
Mean ± Standard Deviation
  46.0  ± 11.31     51.6  ± 9.60     48.2  ± 11.78     48.8  ± 8.78     49.7  ± 10.49     48.9  ± 10.54  
Gender  
[units: participants]
           
Female     44     42     37     38     47     208  
Male     12     15     14     14     16     71  
Race (NIH/OMB)  
[units: participants]
           
American Indian or Alaska Native     3     0     0     0     0     3  
Asian     1     0     0     0     0     1  
Native Hawaiian or Other Pacific Islander     0     0     2     0     0     2  
Black or African American     0     4     1     1     1     7  
White     52     51     46     50     61     260  
More than one race     0     2     2     1     1     6  
Unknown or Not Reported     0     0     0     0     0     0  
BMI  
[units: kg/m^2]
Mean ± Standard Deviation
  27.7  ± 5.95     28.8  ± 5.77     27.4  ± 5.75     28.6  ± 5.41     28.3  ± 5.40     28.2  ± 5.64  



  Outcome Measures
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1.  Primary:   Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)   [ Time Frame: Week 8 ]

Measure Type Primary
Measure Title Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)
Measure Description

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

Time Frame Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vehicle

Injection of vehicle

Placebo Vehicle: Placebo vehicle

Polidocanol Injectable Foam 0.125% Polidocanol injectable foam at a 0.125% concentration
Polidocanol Injectable Foam 0.5% polidocanol injectable foam at a 0.5% concentration
Polidocanol Injectable Foam 1.0% Polidocanol injectable foam at 1.0% concentration
Polidocanol Injectable Foam 2.0% Polidocanol injectable foam at a 2.0% concentration

Measured Values
    Vehicle     Polidocanol Injectable Foam 0.125%     Polidocanol Injectable Foam 0.5%     Polidocanol Injectable Foam 1.0%     Polidocanol Injectable Foam 2.0%  
Number of Participants Analyzed  
[units: participants]
  55     56     51     50     63  
Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)  
[units: units on a scale]
Mean ± Standard Error
  2.13  ± 0.452     4.63  ± 0.447     5.68  ± 0.483     4.87  ± 0.477     5.78  ± 0.425  


Statistical Analysis 1 for Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)
Groups [1] Vehicle vs. Polidocanol Injectable Foam 0.125%
Method [2] ANCOVA
P Value [3] =0.0001
Mean Difference (Final Values) [4] -2.49
95% Confidence Interval ( -3.72 to -1.27 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)
Groups [1] Vehicle vs. Polidocanol Injectable Foam 0.5%
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Final Values) [4] -3.54
95% Confidence Interval ( -4.80 to -2.29 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)
Groups [1] Vehicle vs. Polidocanol Injectable Foam 1.0%
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Final Values) [4] -2.73
95% Confidence Interval ( -3.98 to -1.48 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)
Groups [1] Vehicle vs. Polidocanol Injectable Foam 2.0%
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Final Values) [4] -3.65
95% Confidence Interval ( -4.84 to -2.46 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
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2.  Secondary:   Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)   [ Time Frame: 8 weeks ]

Measure Type Secondary
Measure Title Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)
Measure Description 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).
Time Frame 8 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vehicle

Injection of vehicle

Placebo Vehicle: Placebo vehicle

Polidocanol Injectable Foam 0.125% Polidocanol injectable foam at a 0.125% concentration
Polidocanol Injectable Foam 0.5% Polidocanol injectable foam at a 0.5% concentration
Polidocanol Injectable Foam 1.0% Polidocanol injectable foam at a 1.0% concentration
Polidocanol Injectable Foam 2.0% Polidocanol injectable foam at a 2.0% concentration

Measured Values
    Vehicle     Polidocanol Injectable Foam 0.125%     Polidocanol Injectable Foam 0.5%     Polidocanol Injectable Foam 1.0%     Polidocanol Injectable Foam 2.0%  
Number of Participants Analyzed  
[units: participants]
  55     56     51     50     63  
Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)  
[units: units on a scale]
Mean ± Standard Error
  -0.15  ± 0.143     -0.93  ± 0.142     -1.40  ± 0.152     -1.60  ± 0.151     -1.75  ± 0.135  


Statistical Analysis 1 for Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)
Groups [1] Vehicle vs. Polidocanol Injectable Foam 0.125%
Method [2] ANCOVA
P Value [3] =0.0001
Mean Difference (Final Values) [4] -0.78
95% Confidence Interval ( -1.17 to -0.40 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)
Groups [1] Vehicle vs. Polidocanol Injectable Foam 0.5%
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Final Values) [4] -1.26
95% Confidence Interval ( -1.65 to -0.86 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)
Groups [1] Vehicle vs. Polidocanol Injectable Foam 1.0%
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Final Values) [4] -1.45
95% Confidence Interval ( -1.85 to -1.06 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)
Groups [1] Vehicle vs. Polidocanol Injectable Foam 2.0%
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Final Values) [4] -1.60
95% Confidence Interval ( -1.98 to -1.23 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
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3.  Secondary:   Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance   [ Time Frame: 8 weeks post treatment ]

Measure Type Secondary
Measure Title Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance
Measure Description 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 8 trained, blinded clinicians evaluated the appearance of the patient's visible varicose veins using thre IPR-V3 instrument's 5-point scale (where 0=none to 5=very severe visible varicose veins).
Time Frame 8 weeks post treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Population consists of all patients who had a baseline and on-treatment assessment.

Reporting Groups
  Description
Vehicle

Injection of vehicle

Placebo Vehicle: Placebo vehicle

Polidocanol Injectable Foam 0.125% Polidocanol injectable foam at a 0.125% concentration
Polidocanol Injectable Foam 0.5% Polidocanol injectable foam at a 0.5% concentration
Polidocanol Injectable Foam 1.0% Polidocanol injectable foam at a 1.0% concentration
Polidocanol Injectable Foam 2.0% Polidocanol injectable foam at a 2.0% concentration

Measured Values
    Vehicle     Polidocanol Injectable Foam 0.125%     Polidocanol Injectable Foam 0.5%     Polidocanol Injectable Foam 1.0%     Polidocanol Injectable Foam 2.0%  
Number of Participants Analyzed  
[units: participants]
  55     56     51     49     61  
Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance  
[units: units on a scale]
Mean ± Standard Error
  -0.01  ± 0.081     -0.46  ± 0.080     -0.77  ± 0.086     -0.76  ± 0.085     -0.91  ± 0.077  


Statistical Analysis 1 for Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance
Groups [1] Vehicle vs. Polidocanol Injectable Foam 0.125%
Method [2] ANCOVA
P Value [3] =0.0001
Mean Difference (Final Values) [4] -0.45
95% Confidence Interval ( -0.66 to -0.23 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance
Groups [1] Vehicle vs. Polidocanol Injectable Foam 0.5%
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Final Values) [4] -0.76
95% Confidence Interval ( -0.98 to -0.53 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance
Groups [1] Vehicle vs. Polidocanol Injectable Foam 1.0%
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Final Values) [4] -0.75
95% Confidence Interval ( -0.97 to -0.53 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance
Groups [1] Vehicle vs. Polidocanol Injectable Foam 2.0%
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Final Values) [4] -0.90
95% Confidence Interval ( -1.11 to -0.68 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Wright MB FRCS
Organization: BTG International Inc
phone: 610-278-1660
e-mail: david.wright@btgplc.com


No publications provided


Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01072877     History of Changes
Other Study ID Numbers: VAP.VV015
Study First Received: February 19, 2010
Results First Received: January 15, 2014
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration