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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072877
First Posted: February 22, 2010
Last Update Posted: March 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
BTG International Inc.
Results First Submitted: January 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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

2.  Secondary:   Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)   [ Time Frame: 8 weeks ]
  Hide Outcome Measure 2

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  

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% 
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%
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] =0.0001
Mean Difference (Final Values) [5] -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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.
[5] 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%
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] <0.0001
Mean Difference (Final Values) [5] -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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.
[5] 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%
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] <0.0001
Mean Difference (Final Values) [5] -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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.
[5] 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%
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] <0.0001
Mean Difference (Final Values) [5] -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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.
[5] Other relevant estimation information:
  No text entered.



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 ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01072877     History of Changes
Other Study ID Numbers: VAP.VV015
First Submitted: February 19, 2010
First Posted: February 22, 2010
Results First Submitted: January 15, 2014
Results First Posted: May 16, 2014
Last Update Posted: March 10, 2015