Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.

Official Title

A Dose Ranging Trial for the Evaluation of the Safety, Tolerability and Efficacy of Odiparcil in the Prevention of Venous Thromboembolism Following Total Knee Replacement Surgery

Conditions

  • Venous Thromboembolism
  • Deep Vein Thrombosis
  • Pulmonary Embolism

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

  • Total venous thromboembolism (VTE) event rate after 8 – 12 days of dosing.

Secondary Outcome Measures:

  • Relative risk of VTE at Day 10
  • VTE event rate for odiparcil at Day 10
  • Pharmacodynamic effect as measured by anti-IIa activity at Days 1, 3, 5 and 10
  • Measurements of LFTs and major bleeding anytime during the trial.

Study Start

September 2005

Eligibility & Criteria

  • Ages Eligible for Study: 35 Years and above
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • Women must be unable to have children.
  • Will have a total knee replacement.

Exclusion Criteria:

  • Allergic to any X-ray dye.
  • Allergies or reactions to warfarin or coumadin.
  • Previous VTE (venous thromboembolism) or deep vein thrombosis (DVT).
  • On anticoagulation therapy.
  • Renal impairment.
  • Participated in any clinical trial in the past 30 days.

Total Enrolment

915

Contact Details

  • Box Hill, Victoria, 3128, Australia
  • Windsor, Victoria, 3181, Australia
  • Ringwood East, Victoria, 3185, Australia

Contact GlaxoSmithKline Australia for more details.