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A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery (FONDACAST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00843492
First received: December 11, 2008
Last updated: February 6, 2014
Last verified: June 2012
Results First Received: May 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Thrombosis, Venous
Interventions: Drug: Fondaparinux sodium
Drug: Nadroparin

  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
Nadroparin 2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
Fondaparinux 2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)

Participant Flow:   Overall Study
    Nadroparin     Fondaparinux  
STARTED     622     621  
COMPLETED     614     607  
NOT COMPLETED     8     14  
Adverse Event                 0                 3  
Lost to Follow-up                 4                 4  
Withdrawal by Subject                 0                 4  
Immobilization Stopped                 1                 0  
Investigator/Orthopedic Surgeon Decision                 1                 1  
Orthopedic Surgery                 0                 2  
Visit Not Performed                 1                 0  
Deep-vein Thrombosis                 1                 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.
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Reporting Groups
  Description
Nadroparin 2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
Fondaparinux 2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
Total Total of all reporting groups

Baseline Measures
    Nadroparin     Fondaparinux     Total  
Number of Participants  
[units: participants]
  622     621     1243  
Age [1]
[units: Years]
Mean ± Standard Deviation
     
Years     46.5  ± 15.7     46.1  ± 16.0     46.3  ± 15.8  
Gender [1]
[units: Participants]
     
Female     336     328     664  
Male     286     293     579  
[1] Baseline characteristic data was collected in members of the Intent-to-Treat (ITT) Population, comprised of all randomized patients (recorded in the Interactive Voice Response System [IVRS] database) with a venous thromboembolism (VTE) status or experiencing death.



  Outcome Measures
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1.  Primary:   Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization   [ Time Frame: Day 1 to complete mobilization plus 2 days (average of 35.9 study days) ]

2.  Secondary:   Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death   [ Time Frame: Day 1 to complete mobilization plus 2 days (average of 35.7 study days) ]

3.  Secondary:   Number of Participants With Confirmed VTE and Death up to the Final Visit or Contact   [ Time Frame: Day 1 to 5 weeks (plus or minus 1 week) after complete mobilization (average of 67.8 study days) ]

4.  Secondary:   Number of Participants With Major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact   [ Time Frame: Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days) ]

5.  Secondary:   Number of Participants With Clinically Relevant Non-major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact   [ Time Frame: Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days) ]

6.  Secondary:   Number of Participants With Minor Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact   [ Time Frame: Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days) ]

7.  Secondary:   Participants With Any Incidence of Any Bleeding Event as Adjudicated by a CAC) From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact   [ Time Frame: Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days) ]


  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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  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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00843492     History of Changes
Other Study ID Numbers: 109350
Study First Received: December 11, 2008
Results First Received: May 24, 2012
Last Updated: February 6, 2014
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios
Italy: Comitato Etico della ASL Città di Milano
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Netherlands: De Centrale Commissie Mensgebonden Onderzoek