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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: 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 ]

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


  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