Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01428076
First received: August 30, 2011
Last updated: April 4, 2014
Last verified: April 2014
Results First Received: January 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Varicose Veins
Intervention: Drug: Polidocanol Endovenous Microfoam (PEM)

  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
Polidocanol 1% polidocanol injectable foam 1% concentration
Polidocanol 2% polidocanol injectable foam 2% concentration

Participant Flow:   Overall Study
    Polidocanol 1%     Polidocanol 2%  
STARTED     9     12  
COMPLETED     9     11  
NOT COMPLETED     0     1  
Adverse Event                 0                 1  



  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
Polidocanol 1% polidocanol injectable foam 1% concentration
Polidocanol 2% polidocanol intravenous foam 2% concentration
Total Total of all reporting groups

Baseline Measures
    Polidocanol 1%     Polidocanol 2%     Total  
Number of Participants  
[units: participants]
  9     12     21  
Age  
[units: years]
Mean ± Standard Deviation
  54.0  ± 9.62     49.9  ± 11.4     51.7  ± 10.6  
Gender  
[units: participants]
     
Female     6     6     12  
Male     3     6     9  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     9     12     21  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
BMI  
[units: kg/m^2]
Mean ± Standard Deviation
  27.1  ± 2.52     27.1  ± 5.19     27.1  ± 4.16  



  Outcome Measures

1.  Primary:   Weight-adjusted Polidocanol Cmax (Serum)   [ Time Frame: pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose ]


  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: NCT01428076     History of Changes
Other Study ID Numbers: VAP.VV008
Study First Received: August 30, 2011
Results First Received: January 15, 2014
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration