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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:
ClinicalTrials.gov Identifier:
NCT00443053
First Posted: March 5, 2007
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: July 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Thrombosis, Venous
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 
Other                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 
Overall Participants Analyzed 
[Units: Participants]
 1502   1500   3002 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.1  (13.29)   56.9  (13.56)   57.0  (13.43) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      974  64.8%      944  62.9%      1918  63.9% 
Male      528  35.2%      556  37.1%      1084  36.1% 
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 ]

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
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Time Frame No text entered.
Additional Description Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.

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

Serious Adverse Events
    Fondaparinux 2.5 mg   Placebo
Total, Serious Adverse Events     
# participants affected / at risk   10/1499 (0.67%)   16/1488 (1.08%) 
Cardiac disorders     
Angina pectoris † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Atrial fibrillation † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Cardiac failure acute † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Coronary artery disease † 1     
# participants affected / at risk   0/1499 (0.00%)   2/1488 (0.13%) 
Myocardial infarction † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Right ventricular failure † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Intestinal obstruction † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Hepatobiliary disorders     
Billiary colic † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Cholelithiasis † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Infections and infestations     
Erysipelas † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Haematoma infection † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Peritonsillar abscess † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Prostatic abscess † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Staphylococcal infection † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Injury, poisoning and procedural complications     
Fall † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Road traffic accident † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Musculoskeletal and connective tissue disorders     
Fasciitis † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Pain in extremity † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bile duct cancer † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Pancreatic carcinoma stage IV † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Nervous system disorders     
Cerebrovascular accident † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Vertebrobasilar insufficiency † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Renal and urinary disorders     
Renal colic † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Renal cyst † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Urethral obstruction † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Reproductive system and breast disorders     
Menometrorrhagia † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Henoch-Schonlein purpura † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Petechiae † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Vascular disorders     
Circulatory collapse † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Hypertensive crisis † 1     
# participants affected / at risk   0/1499 (0.00%)   1/1488 (0.07%) 
Jugular vein thrombosis † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Subclavian vein thrombosis † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Vena cave thrombosis † 1     
# participants affected / at risk   1/1499 (0.07%)   0/1488 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)




  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