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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
History of Changes
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 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)   [ Time Frame: 8 weeks ]
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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 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).
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.
patients with a baseline and week 8 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, experimental dose 1.0%

Measured Values
    Vehicle     Polidocanol Injectable Foam, 0.125%     Polidocanol Injectable Foam, 0.5%     Polidocanol Injectable Foam, 1.0%  
Number of Participants Analyzed  
[units: participants]
 		  56     56     60     57  
Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)  
[units: units on a scale]
Mean (Standard Error) 		  -0.07  (0.080)     -0.74  (0.081)     -0.89  (0.078)     -0.83  (0.080)  


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] -0.66
Standard Error of the mean (0.081)
95% Confidence Interval -0.88 to -0.45
[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] -0.82
Standard Error of the mean (0.078)
95% Confidence Interval -1.04 to -0.61
[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] -0.75
95% Confidence Interval -0.97 to -0.54
[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.



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


  Serious Adverse Events
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  Other Adverse Events
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  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


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


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