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Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)

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ClinicalTrials.gov Identifier: NCT00320398
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : December 21, 2017
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE May 1, 2006
First Posted Date  ICMJE May 3, 2006
Results First Submitted Date  ICMJE May 12, 2017
Results First Posted Date  ICMJE December 21, 2017
Last Update Posted Date September 3, 2018
Actual Study Start Date  ICMJE January 30, 2006
Actual Primary Completion Date July 18, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
  • Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period [ Time Frame: Up to Day 17 ]
    The percentage of participants with VTE, who underwent elective total hip replacement surgery, detected by routine venography, during the treatment period were reported. The percentage VTE was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).
  • Percentage of Participants With Major Bleeding [ Time Frame: Up to Day 17 ]
    Major bleeding defined as any clinically unusual bleeding meeting 1 of following criteria; a)Fatal bleeding; b) Including retroperitoneal and intracranial bleeding, or bleeding into critical organ (eye, adrenal gland, pericardium, spine); c) Reoperation due to bleeding or hematoma at operative site; d)Bleeding leading to hemoglobin (Hb) fall > = 2 gram per deciliter (g/dL)(1.6 millimole per litre [mmol/L]) within 48 hour of the bleed; e)Bleeding that required transfusion of red blood cells (RBCs) or whole blood (WB) derived from >= 900 milliliter (mL) of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) >=2. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE.
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2006)
Rate of VTE (venous thromboembolism) rate and major bleeding
Change History Complete list of historical versions of study NCT00320398 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
  • Percentage of Participants With Minor Bleeding [ Time Frame: Up to Day 17 ]
    Minor bleeding was defined as the clinically overt bleeding not meeting the criteria for major bleeding like: (Fatal bleed; Including retroperitoneal and intracranial bleeding, or bleed in critical organ [eye, adrenal gland, pericardium, spine]; c) Reoperation due to bleeding or hematoma at operative site; d) Bleeding leading to hemoglobin (Hb) fall > = 2 g/dL(1.6 mmol/L) within 48 hour of the bleed; e)Bleeding that required transfusion of RBCs or WB derived from >= 900 mL of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) >=2), and which were considered more than expected in the clinical context. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE.
  • Percentage of Participants With All Deep Vein Thrombosis (DVT) [ Time Frame: Up to Day 17 ]
    The percentage of participants with All DVT were reported, where the analysis was done using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.
  • Percentage of Participants With Proximal DVT [ Time Frame: Up to Day 17 ]
    The percentage of participants with DVT (proximal) were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.
  • Percentage of Participants With Distal Only DVT [ Time Frame: Up to Day 17 ]
    The percentage of participants with distal only DVT were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.
  • Percentage of Participants With Symptomatic DVT During Main Efficacy Period [ Time Frame: Up to Day 17 ]
    The percentage of participants with different symptoms of DVT (proximal) like pain or tenderness, swelling, warmth, redness or discoloration, and distention of surface veins, post the total hip replacement surgery were reported, where analysis was done using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.
  • Percentage of Participants With Pulmonary Embolism During Efficacy Period [ Time Frame: Up to Day 17 ]
    The percentage of participants with pulmonary embolism (pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia ) were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths [ Time Frame: From first injection of study drug (Day 3) to up to 2 calendar days after last injection (Treatment period), up to Day 17. ]
    An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
  • Number of Transfused Participants [ Time Frame: Up to Day 17. ]
    The number of participants who received RBCs or WB after the total hip replacement surgery within 48 hours of bleed were reported.
  • Volume of Transfusion [ Time Frame: Up to Day 17 ]
    The total volume of transfusion (RBCs or WB) received by the participant was reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2006)
Rate of DVT(deep vein thrombosis) [proximal, distal] and PE.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)
Official Title  ICMJE Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Elective Total Hip Replacement Surgery
Brief Summary This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Condition  ICMJE Thrombosis, Venous
Intervention  ICMJE Drug: Fondaparinux
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2017)
114
Original Enrollment  ICMJE
 (submitted: May 1, 2006)
100
Actual Study Completion Date  ICMJE July 18, 2006
Actual Primary Completion Date July 18, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing either an elective primary THR (total hip replacement) surgery or a revision of a THR.

Exclusion Criteria:

  • Active, clinically significant bleeding (excluding drainage).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Japan
 
Administrative Information
NCT Number  ICMJE NCT00320398
Other Study ID Numbers  ICMJE AR3106333
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP