A Dose Ranging Trial for the Evaluation of the Safety,Tolerability and Efficacy of Odiparcil in the Prevention ofVenous Thromboembolism following Total Knee ReplacementSurgery.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 640

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

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 with a past history of hepatitis B or C.
15. Subjects with know gastric bypass, malabsorbtion sydrome or short gut sydrome.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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