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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, 2014
Last verified: February 2014
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: Vehicle
Drug: polidocanol injectable foam, 1.0%
Drug: polidocanol injectable foam, 0.125%
Drug: polidocanol injectable foam, 0.5%

  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     59     58     60     58  
COMPLETED     56     57     60     57  
NOT COMPLETED     3     1     0     1  
Withdrawal by Subject                 2                 0                 0                 0  
Lost to Follow-up                 0                 0                 0                 1  
Withdrew consent                 1                 1                 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:   The Absolute Change From Baseline in Patient Symptom Assessment Score (Called VVSymQ).   [ Time Frame: 8 weeks ]

2.  Secondary:   Change in Varicose Vein Appearance as Rated by Blinded Central Independent Physician Photography Review   [ Time Frame: 8 weeks ]

3.  Secondary:   Absolute Change From Baseline to Week 8 (PA-V3; Patient Assessment of Varicose Vein Appearance)   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Vehicle     Polidocanol Injectable Foam, 0.125%     Polidocanol Injectable Foam, 0.5%     Polidocanol Injectable Foam, 1.0%  
Total, other (not including serious) adverse events          
# participants affected / at risk     11/59     24/58     27/60     47/58  
General disorders          
Infusion site thrombosis † 1        
# participants affected / at risk     0/59 (0.00%)     6/58 (10.34%)     7/60 (11.67%)     16/58 (27.59%)  
# events     0     6     7     16  
Tenderness † 1        
# participants affected / at risk     0/59 (0.00%)     0/58 (0.00%)     1/60 (1.67%)     4/58 (6.90%)  
# events     0     0     1     4  
Musculoskeletal and connective tissue disorders          
Pain in extremity † 1        
# participants affected / at risk     7/59 (11.86%)     9/58 (15.52%)     4/60 (6.67%)     10/58 (17.24%)  
# events     7     9     4     10  
Limb discomfort † 1        
# participants affected / at risk     2/59 (3.39%)     1/58 (1.72%)     2/60 (3.33%)     3/58 (5.17%)  
# events     2     1     2     3  
Back pain † 1        
# participants affected / at risk     3/59 (5.08%)     0/58 (0.00%)     0/60 (0.00%)     1/58 (1.72%)  
# events     3     0     0     1  
Vascular disorders          
Thrombophlebitis superficial † 1        
# participants affected / at risk     1/59 (1.69%)     4/58 (6.90%)     8/60 (13.33%)     2/58 (3.45%)  
# events     1     4     8     2  
Venous thrombosis limb † 1        
# participants affected / at risk     0/59 (0.00%)     2/58 (3.45%)     2/60 (3.33%)     4/58 (6.90%)  
# events     0     2     2     4  
Hematoma † 1        
# participants affected / at risk     1/59 (1.69%)     2/58 (3.45%)     3/60 (5.00%)     3/58 (5.17%)  
# events     1     2     3     3  
Deep vein thrombosis † 1        
# participants affected / at risk     0/59 (0.00%)     0/58 (0.00%)     0/60 (0.00%)     5/58 (8.62%)  
# events     0     0     0     5  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.1



  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
No text entered.


  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, 2014
Health Authority: United States: Food and Drug Administration