Last updated: 11/04/2018 08:27:58

Odiparcil For The Prevention Of Venous Thromboembolism

GSK study ID
ITI101711
Clinicaltrials.gov ID
NCT00244725
See results summary
EudraCT ID
2004-000610-39
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Percentage of participants with total VTE event over 10 ± 2 days of treatment

Timeframe: Up to Visit 7 (10 ± 2 days of treatment)

Secondary outcomes:

Percentage of participants with proximal DVT over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Percentage of participants with distal DVT over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Percentage of participants with PE over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Number of death due to VTE over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Percentage of participants with total asymptomatic VTE over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Percentage of total symptomatic VTE over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Concentration of Trough Anti-IIa Activity over the duration of treatment and follow-up

Timeframe: Up to 68 days

Percentage of participants with major bleeds over 10 ± 2 days of treatment

Timeframe: Up to 12 days

Percentage of participants with VTE and/or major bleeding over 10±2 days of treatment

Timeframe: Up to 12 days

Percentage of participants with total VTE any time after start of treatment

Timeframe: Up to Visit 9 (Day 28 post treatment)

Percentage of participants with elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin (DB) and total bilirubin (TB) by 2 fold and 3 fold from upper normal limits (ULN) any time on-treatment

Timeframe: Up to 12 days

Interventions:
  • Drug: Odiparcil
  • Drug: Warfarin
  • Drug: Coumadin
    • Enrollment:
    961
    Primary completion date:
    2006-15-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Deep Vein Thrombosis, Fibrillation, Atrial, Pulmonary Embolism
    Product
    odiparcil
    Collaborators
    Not applicable
    Study date(s)
    September 2005 to September 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    35 years - 0 Not applicable
    Accepts healthy volunteers
    No
    • Women must be unable to have children.
    • Will have a total knee replacement.
    • Allergic to any X-ray dye.
    • Allergies or reactions to warfarin or coumadin.
    Inclusion and exclusion criteria
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85023
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lubbock, Texas, United States, 79410
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Baton Rouge, Louisiana, United States, 70808
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ajax, Ontario, Canada, L1S 2J5
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Sarsota, Florida, United States, 34239
    Status
    Study Complete
    Contact us
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    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-15-09
    Actual study completion date
    2006-15-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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