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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:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01072877
First received: February 19, 2010
Last updated: February 19, 2015
Last verified: February 2015
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 
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
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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 ]

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
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Time Frame No text entered.
Additional Description 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
Polidcanol 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 Endovenous Microfoam 2.0% polidocanol injectable foam at a 2.0% concentration

Serious Adverse Events
    Vehicle   Polidocanol Injectable Foam 0.125%   Polidcanol Injectable Foam 0.5%   Polidocanol Injectable Foam 1.0%   Polidocanol Endovenous Microfoam 2.0%
Total, serious adverse events           
# participants affected / at risk   0/56 (0.00%)   0/57 (0.00%)   0/51 (0.00%)   0/52 (0.00%)   0/63 (0.00%) 




  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
Study First Received: February 19, 2010
Results First Received: January 15, 2014
Last Updated: February 19, 2015
Health Authority: United States: Food and Drug Administration