Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Endovenous Microfoam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence (Pilot)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT00758420
First received: September 22, 2008
Last updated: February 25, 2014
Last verified: February 2014
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Varicose Veins
Interventions: Drug: Varisolve (Polidocanol Endovenous Microfoam)
Drug: Agitated Saline

  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
Active Treatment polidocanol injectiable foam 1%, up to 15 mL, one treatment session
Placebo

Agitated saline

Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session


Participant Flow:   Overall Study
    Active Treatment     Placebo  
STARTED     38     39  
COMPLETED     38     39  
NOT COMPLETED     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.
Treated patients with a week 8 study assessment.

Reporting Groups
  Description
Placebo Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment sessionpolidocanol
Polidocanol Injectable Foam, 1.0% injectiable foam 1%, up to 15 mL, one treatment session
Total Total of all reporting groups

Baseline Measures
    Placebo     Polidocanol Injectable Foam, 1.0%     Total  
Number of Participants  
[units: participants]
  38     39     77  
Age  
[units: years]
Mean ± Standard Deviation
  44.9  ± 10.71     45.3  ± 10.75     45.1  ± 10.66  
Gender  
[units: participants]
     
Female     32     30     62  
Male     6     9     15  
Baseline VCSS [1]
[units: units on a scale]
Mean ± Standard Deviation
  6.0  ± 1.95     6.6  ± 2.05     6.3  ± 2.01  
CEAP Clinical classification [2]
[units: participants]
     
C3 – Edema     34     35     69  
C4 - Skin Change Without Ulceration     4     2     6  
C5 - Skin Change With Healed Ulceration     0     2     2  
VVSymQ Score [3]
[units: units on a scale]
Mean ± Standard Deviation
  57.5  ± 27.97     52.6  ± 29.37     55.0  ± 28.60  
VEINES-Sym Score [4]
[units: units on a scale]
Mean ± Standard Deviation
  61.9  ± 26.05     59.3  ± 26.11     60.6  ± 25.94  
[1] The Venous Clinical Severity Score (VCSS) was determined by a study staff member blinded to treatment assignment, (i.e., the ‘blinded assessor’). The VCSS rates 9 clinical characteristics of chronic venous disease (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, and number, duration, and size of ulcers) using Grades 0 to 3 (absent to severe). An additional 0 to 3 points are added for differences in use of compression therapy (compression and elevation) to produce a 30-point maximum flat scale.
[2] Patients were eligible for study if they had a clinical classification of C2–C5 as follows: C2 Varicose veins C3 Edema C4 Skin changes without ulceration C5 Skin changes with healed ulceration Etiology of disease was classified as congenital, primary or secondary disease; anatomic findings were indicated as superficial veins, deep veins, or perforating veins; and the pathophysiologic component was classified as reflux, obstruction or both.
[3] The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = [(Raw Score) – 5] * 4
[4] The VEINES-Sym summary score includes 10 items 9 venous symptoms (heavy legs, aching legs, swelling, night cramps, heat or burning sensation, restless legs, throbbing, itching, tingling sensation), rated on a 6-point scale of frequency and leg pain rated on a 6-point scale of intensity (very severe, severe, moderate, mild, very mild, none) it can range from 0 to 100, with a ‘0’ score indicating all symptoms were present all of the time in the past week and a ‘100’ score indicating none of the symptoms were present



  Outcome Measures

1.  Primary:   The Absolute Change From Baseline Score for the WWSymQ (Varicose Veins Symptom Questionnaire Overall Score) at 8 Weeks   [ Time Frame: Baseline to 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: David Wright MBBS
Organization: BTG International Inc.
phone: 610-943-3538
e-mail: david.wright@btgplc.com


No publications provided


Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00758420     History of Changes
Other Study ID Numbers: VAP.VV013
Study First Received: September 22, 2008
Results First Received: January 6, 2014
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration