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
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
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.
No text entered.

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 ]

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 ]
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Measure Type Secondary
Measure Title Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77
Measure Description Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated “On-Treatment,” defined as from randomization up to the last injection +4 days.
Time Frame Days 47 (or last dose plus 4 days) 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.
As-Treated 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]
  1499     1488  
Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77  
[units: events]
   
Day 47     5     8  
Day 77     6     9  

No statistical analysis provided for Number of Adjudicated Non-Major Bleeding Events at Days 47 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


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00443053     History of Changes
Other Study ID Numbers: ART108053
Study First Received: March 2, 2007
Results First Received: July 2, 2010
Last Updated: February 7, 2013
Health Authority: Netherlands: Medicines Evaluation Board (MEB)