Venous Thromboembolism
Conditions
Interventions
Product Name: Odiparcil
Product Code: SB424323
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Odiparcil
Current Spons
Sponsors
GlaxoSmithKline Research and Development Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be considered eligible for inclusion in this study only if all of the following criteria apply: 1. Male or female subjects =35 years of age who are scheduled for primary elective unilateral total knee arthroplasty (i.e. first time the knee is being replaced on the operative side). 2. Subjects who have given written informed consent to participate. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. Females who are not surgically sterile or postmenopausal (>1 year since their last menstrual period with a follicle stimulating hormone (FSH) level of >30 ImU/ml). Surgically sterile includes total hysterectomy or oophrectomy, however tubal ligation is not accepted as surgically sterile by the sponsor. 2. Subjects with a contraindication to contrast venography such as an allergy to the contrast medium 3. Subjects with moderate to severely impaired renal function as defined by a. a serum creatinine concentration =2.0 mg/dL or 177 micromol/L at Screening 4. Subjects with transaminase levels (ALT or AST) > ULN at Screening 5. Subjects with a presumed increased risk of intra and post operative bleeding or requiring greater than four units of packed red blood cells intraoperatively. 6. Subjects with a history of objectively diagnosed DVT or PE. 7. Subjects with a contraindication to warfarin or a history of intolerance to warfarin or history of protein C/S etc. deficiency. 8. Subjects with an ongoing requirement (other than for prophylaxis following TKR surgery) for any antithrombotic drug therapy such as a vitamin K antagonist, heparin (standard unfractionated or low molecular weight), heparinoid, direct thrombin inhibitor, GPIIb/IIIa receptor antagonist, thrombolytic agent, dextran, aggrenox, clopidogrel, or ticlopidine. 9. Subjects who have received an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study. 10. Subjects with clinically significant neurologic, endocrine, or psychiatric abnormalities which are uncontrolled on permitted therapy. 11. At the investigators discretion subjects with a suspected history of drug or alcohol abuse or subjects who are deemed unsuitable for the trial. 12. Subjects who will be inaccessible due to geographic or social factors during treatment or follow-up. 13. Subjects who received epidural/spinal anesthesia and will or can not have the catheter removed at least 4 hours prior to the first dose of study medication. 14. Subjects that are self identified as being of Japanese heritage. 15. Subjects with know gastric bypass, malabsorption syndrome or short gut syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to assess the safety and efficacy of odiparcil in the prevention of VTE following TKR and to provide evidence to enable the selection of a single dose of odiparcil for future investigation.; Secondary Objective: The secondary objective of this trial is to characterize the dose response, and PK/PD relationship of odiparcil. ; Primary end point(s): The primary endpoint of the trial is the incidence of total VTE (proximal and distal deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE) and death due to VTE). This includes any asymptomatic DVT assessed by mandatory bilateral venography at the end of the study or at early withdrawal, symptomatic DVT confirmed by objective testing, or symptomatic PE confirmed by objective testing at any time during the study. Any deaths related to VTE that occur during the study or any subjects withdrawn from the Double-blind Treatment Period due to objectively confirmed symptomatic VTE will be included in the incidence. | — |
Countries
Latvia, Lithuania, United Kingdom
Outcome results
None listed