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 ]
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Measure Type Secondary
Measure Title Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77
Measure Description VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.
Time Frame Baseline to Day 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 Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77  
[units: participants]
  18     94  


Statistical Analysis 1 for Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] <0.001
Risk Ratio (RR) [4] 0.19
95% Confidence Interval ( 0.12 to 0.32 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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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 ]

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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