Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00443053
First received: March 2, 2007
Last updated: February 7, 2013
Last verified: February 2012
Results First Received: July 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Thrombosis, Venous
Superficial Thrombophlebitis
Intervention: Drug: Fondaparinux 2.5mg or placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Fondaparinux 2.5 mg Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
Placebo Matching placebo

Participant Flow:   Overall Study
    Fondaparinux 2.5 mg     Placebo  
STARTED     1502     1500  
COMPLETED     1481     1467  
NOT COMPLETED     21     33  
Adverse Event                 2                 1  
Withdrawal by Subject                 9                 18  
Lost to Follow-up                 4                 5  
Did Not Meet Eligibility Criteria                 1                 0  
Noncompliance                 2                 1  
Unknown                 3                 4  
Physician Decision                 0                 4  



  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.
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Reporting Groups
  Description
Fondaparinux 2.5 mg Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
Placebo Matching placebo
Total Total of all reporting groups

Baseline Measures
    Fondaparinux 2.5 mg     Placebo     Total  
Number of Participants  
[units: participants]
  1502     1500     3002  
Age  
[units: years]
Mean ± Standard Deviation
  57.1  ± 13.29     56.9  ± 13.56     57.0  ± 13.43  
Gender  
[units: participants]
     
Female     974     944     1918  
Male     528     556     1084  
Race/Ethnicity, Customized  
[units: participants]
     
White, European Heritage     1485     1492     2977  
Arabic/North African Heritage     15     4     19  
African American Heritage     0     2     2  
Asian/South Asian Heritage     0     1     1  
Mixed Race     1     0     1  
Missing     1     1     2  



  Outcome Measures
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1.  Primary:   Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47   [ Time Frame: Baseline to Day 47 ]

2.  Secondary:   Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77   [ Time Frame: Baseline to Day 77 ]

3.  Secondary:   Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77   [ Time Frame: Days 47 and 77 ]
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Measure Type Secondary
Measure Title Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77
Measure Description VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within <=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length.
Time Frame Days 47 and 77  
Safety Issue No  

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.
ITT Population

Reporting Groups
  Description
Fondaparinux 2.5 mg Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
Placebo Matching placebo

Measured Values
    Fondaparinux 2.5 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  1502     1500  
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77  
[units: participants]
   
Participants with at least one event, D 47     13     88  
Death, D 47     2     1  
Symptomatic PE, D 47     0     5  
Symptomatic DVT, D 47     3     18  
Symptomatic recurrence of SVT, D 47     5     24  
Symptomatic extension of SVT, D 47     4     51  
Participants with at least one event, D 77     18     94  
Death, D 77     2     1  
Symptomatic PE, D 77     0     6  
Symptomatic DVT, D 77     4     19  
Symptomatic recurrence of SVT, D 77     8     26  
Symptomatic extension of SVT, D 77     5     54  

No statistical analysis provided for Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77



4.  Secondary:   Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77   [ Time Frame: Days 47 and 77 ]

5.  Secondary:   Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77   [ Time Frame: Days 47 (or last dose plus 4 days) and 77 ]

6.  Secondary:   Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77   [ Time Frame: Days 47 (or last dose plus 4 days) and 77 ]

7.  Secondary:   Number of Any Adjudicated Bleeding Events at Days 47 and 77   [ Time Frame: Days 47 (or last dose plus 4 days) and 77 ]


  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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