Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01231373
First received: October 22, 2010
Last updated: February 19, 2015
Last verified: February 2015
Results First Received: December 20, 2013  
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, 0.125%
Drug: polidocanol injectable foam, 0.5%
Drug: polidocanol injectable foam, 1.0%
Drug: 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
Three (3) patients were randomized but never treated.

Reporting Groups
  Description
Vehicle Vehicle: Injection of vehicle comparator
Polidocanol Injectable Foam, 0.125% active placebo for blinding of therapeutic polidocanol dose
Polidocanol Injectable Foam, 0.5% lower experimental polidocanol dose
Polidocanol Injectable Foam, 1.0% 1.0% polidocanol foam injection

Participant Flow:   Overall Study
    Vehicle     Polidocanol Injectable Foam, 0.125%     Polidocanol Injectable Foam, 0.5%     Polidocanol Injectable Foam, 1.0%  
STARTED     59     58     60     58  
Patients Receiving Blinded Treatment     57     57     60     58  
COMPLETED     56     57     60     57  
NOT COMPLETED     3     1     0     1  
Withdrew consent prior to randomization                 2                 1                 0                 0  
Lost to Follow-up                 0                 0                 0                 1  
Withdrew Consent                 1                 0                 0                 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.
Patients receiving blinded treatment

Reporting Groups
  Description
Vehicle Vehicle: Injection of vehicle comparator
Polidocanol Injectable Foam, 0.125% polidocanol injectable foam active placebo
Polidocanol Injectable Foam, 0.5% polidocanol injectable foam lower experimental dose
Polidocanol Injectable Foam, 1.0% polidocanol injectable foam therapeutic dose
Total Total of all reporting groups

Baseline Measures
    Vehicle     Polidocanol Injectable Foam, 0.125%     Polidocanol Injectable Foam, 0.5%     Polidocanol Injectable Foam, 1.0%     Total  
Number of Participants  
[units: participants]
  57     57     60     58     232  
Age  
[units: years]
Mean ± Standard Deviation
  49.8  ± 10.44     52.8  ± 10.06     50.4  ± 9.89     50.4  ± 11.42     50.8  ± 10.47  
Gender  
[units: participants]
         
Female     42     43     40     44     169  
Male     15     14     20     14     63  
Race/Ethnicity, Customized  
[units: participants]
         
White     54     53     55     53     215  
Black     2     1     3     0     6  
Asian     0     1     0     1     2  
American Indian/Eskimo     0     0     0     1     1  
Other     1     2     2     3     8  
Weight  
[units: kilograms]
Mean ± Standard Deviation
  83.0  ± 20.22     85.3  ± 16.41     88.8  ± 22.66     81.4  ± 20.22     84.8  ± 20.11  
Height  
[units: centimeters]
Mean ± Standard Deviation
  169.7  ± 9.45     168.6  ± 9.38     169.6  ± 10.47     169.1  ± 9.27     169.3  ± 9.61  
Calculated BMI  
[units: kg/m^2]
Mean ± Standard Deviation
  28.8  ± 5.76     30.1  ± 19.48     30.7  ± 6.28     28.4  ± 6.45     29.5  ± 6.03  



  Outcome Measures
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1.  Primary:   Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score)   [ Time Frame: 8 weeks ]
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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 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.
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.
Number of subjects with a baseline value (VVSymQ) and value at the 8 week visit.

Reporting Groups
  Description
Vehicle Vehicle: Injection of vehicle comparator
Polidocanol Injectable Foam, 0.125% polidocanol injectable foam, 0.125%: active placebo for blinding
Polidocanol Injectable Foam, 0.5% experimental dose polidocanol injectable foam, 0.5%
Polidocanol Injectable Foam, 1.0% polidocanol injectable foam, 1.0%: Injection of mid-dose PEM

Measured Values
    Vehicle     Polidocanol Injectable Foam, 0.125%     Polidocanol Injectable Foam, 0.5%     Polidocanol Injectable Foam, 1.0%  
Number of Participants Analyzed  
[units: participants]
  54     54     60     57  
Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score)  
[units: units on a scale]
Least Squares Mean ± Standard Error
  -2.00  ± 0.474     -5.34  ± 0.476     -6.01  ± 0.454     -5.06  ± 0.463  


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] -3.34
95% Confidence Interval ( -4.63 to -2.04 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of polidocanol treatment groups versus placebo (absolute change from baseline to week 8 in patient assessment of symptoms of varicose veins (VVSymQ) score.
[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] -4.00
95% Confidence Interval ( -5.26 to -2.74 )
[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] -3.05
95% Confidence Interval ( -4.33 to -1.77 )
[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.



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

3.  Secondary:   Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance   [ Time Frame: 8 weeks ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Wright MBBS
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: NCT01231373     History of Changes
Other Study ID Numbers: VAP.VV016
Study First Received: October 22, 2010
Results First Received: December 20, 2013
Last Updated: February 19, 2015
Health Authority: United States: Food and Drug Administration