Odiparcil For The Prevention Of Venous Thromboembolism

March 21, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

961

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • GSK Investigational Site
    • Queensland
      • Southport, Queensland, Australia, 4215
        • GSK Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • GSK Investigational Site
      • Clayton, Victoria, Australia, 3168
        • GSK Investigational Site
      • Geelong, Victoria, Australia, 3220
        • GSK Investigational Site
      • Ringwood East, Victoria, Australia, 3135
        • GSK Investigational Site
      • Windsor, Victoria, Australia, 3181
        • GSK Investigational Site
  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • GSK Investigational Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
        • GSK Investigational Site
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3J 3M7
        • GSK Investigational Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • GSK Investigational Site
      • Don Mills, Ontario, Canada, M3C 1W3
        • GSK Investigational Site
      • Newmarket, Ontario, Canada, L3Y 2P9
        • GSK Investigational Site
      • North York, Ontario, Canada, M3M 2G2
        • GSK Investigational Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • GSK Investigational Site
      • Scarborough, Ontario, Canada, M1W 3W3
        • GSK Investigational Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • GSK Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 1L2
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • GSK Investigational Site
      • Québec, Quebec, Canada, G1J 1Z4
        • GSK Investigational Site
      • Sainte Jerome, Quebec, Canada, J7Z 5T3
        • GSK Investigational Site
  • India
      • Chennai, India, 600 040
        • GSK Investigational Site
      • Secunderabad, India, 500 003
        • GSK Investigational Site
  • Israel
      • Haifa, Israel, 31096
        • GSK Investigational Site
      • Kfar Saba, Israel, 44281
        • GSK Investigational Site
      • Petach Tikva, Israel, 49372
        • GSK Investigational Site
      • Tel-Aviv, Israel, 64239
        • GSK Investigational Site
  • Latvia
      • Riga, Latvia, LV1004
        • GSK Investigational Site
      • Riga, Latvia, LV1005
        • GSK Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • GSK Investigational Site
      • Klaipeda, Lithuania, LT-92288
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-04128
        • GSK Investigational Site
  • Poland
      • Bialystok, Poland, 15-276
        • GSK Investigational Site
      • Krakow, Poland, 31-862
        • GSK Investigational Site
      • Sosnowiec, Poland, 41-200
        • GSK Investigational Site
      • Wroclaw, Poland, 50-043
        • GSK Investigational Site
  • Russian Federation
      • Irkutsk, Russian Federation, 664003
        • GSK Investigational Site
      • Kurgan, Russian Federation, 640014
        • GSK Investigational Site
      • Moscow, Russian Federation, 117415
        • GSK Investigational Site
      • Mosocow, Russian Federation, 115516
        • GSK Investigational Site
      • Mosocow, Russian Federation, 117593
        • GSK Investigational Site
      • Rostov- on- Don, Russian Federation, 344718
        • GSK Investigational Site
  • South Africa
      • Centurion, South Africa, 157
        • GSK Investigational Site
      • Pretoria, South Africa
        • GSK Investigational Site
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0084
        • GSK Investigational Site
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • GSK Investigational Site
      • Dnepropetrovsk, Ukraine, 49005
        • GSK Investigational Site
      • Kyiv, Ukraine, 03103
        • GSK Investigational Site
      • Kyiv, Ukraine, 04107
        • GSK Investigational Site
      • Vinnitsa, Ukraine, 21032
        • GSK Investigational Site
  • United Kingdom
      • Bournmouth, United Kingdom, BH7 7DW
        • GSK Investigational Site
      • Fife, United Kingdom, KY2 5AH
        • GSK Investigational Site
      • London, United Kingdom, SE5 9JP
        • GSK Investigational Site
      • Wigan, United Kingdom, WN6 9EP
        • GSK Investigational Site
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B18 7QH
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • GSK Investigational Site
      • Mobile, Alabama, United States, 36608
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Banning, California, United States, 92220
        • GSK Investigational Site
      • Sacramento, California, United States, 95817
        • GSK Investigational Site
      • Torrance, California, United States, 90509
        • GSK Investigational Site
      • Yuba City, California, United States, 95991
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • GSK Investigational Site
      • Lonetree, Colorado, United States, 80124
        • GSK Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • GSK Investigational Site
      • Deland, Florida, United States, 32720
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32216
        • GSK Investigational Site
      • Sarasota, Florida, United States, 34239
        • GSK Investigational Site
      • Sarsota, Florida, United States, 34239
        • GSK Investigational Site
      • St. Petersburg, Florida, United States, 33701
        • GSK Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30033
        • GSK Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21218
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21215-5271
        • GSK Investigational Site
    • Michigan
      • Warren, Michigan, United States, 48089
        • GSK Investigational Site
    • New York
      • Mineola, New York, United States, 11501
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • GSK Investigational Site
      • Durham, North Carolina, United States, 27704
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44195
        • GSK Investigational Site
      • Toledo, Ohio, United States, 43614
        • GSK Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • GSK Investigational Site
      • Altoona, Pennsylvania, United States, 16601
        • GSK Investigational Site
      • Camp Hill, Pennsylvania, United States, 17011
        • GSK Investigational Site
      • Hershey, Pennsylvania, United States, 17033
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Dallas, Texas, United States, 75231
        • GSK Investigational Site
      • Lubbock, Texas, United States, 79410
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78217
        • GSK Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23249
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23229
        • GSK Investigational Site
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • GSK Investigational Site
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment
Time Frame: Up to Visit 7 (10 ± 2 days of treatment)
Participants were assessed for VTE at all study visits and at the end of study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study did not receive a mandatory bilateral venogram following at least 8 days on study medication. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if he/ she experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or pulmonary embolism (PE) at any time during study treatment or death adjudicated to be related to VTE during study treatment.
Up to Visit 7 (10 ± 2 days of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment
Time Frame: Up to 12 days
Proximal DVT is defined as DVT in or above the popliteal vein. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was 'Yes' or 'No', and to have had an adjudicated asymptomatic DVT if the answer was 'Yes'. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question 'Was a symptomatic DVT identified?' was 'Yes' and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a proximal DVT if either of the ICAC answers to the questions 'Left proximal' and 'Right proximal' was 'DVT'. Percentage of participants with proximal DVT over 10 ± 2 days of treatment were reported.
Up to 12 days
Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment
Time Frame: Up to 12 days
A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was 'Yes' or 'No', and to have had an adjudicated asymptomatic DVT if the answer was 'Yes'. A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question 'Was a symptomatic DVT identified?' was 'Yes' and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. In both asymptomatic and symptomatic DVT, the participant was considered to had a distal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' is 'DVT'.
Up to 12 days
Percentage of Participants With PE Over 10 ± 2 Days of Treatment
Time Frame: Up to 12 days
Participant who reported symptoms of PE were considered to have had an adjudicated objectively confirmed symptomatic PE if the ICAC answer to the question 'Was a PE identified?' was 'Yes'. E was characterized as fatal PE non-fatal PE and total PE events. Data has been presented for fatal PE non-fatal PE and total PE events over 12 days.
Up to 12 days
Number of Death Due to VTE Over 10 ± 2 Days of Treatment
Time Frame: Up to 12 days
A participant was considered dead from an adjudicated VTE-related cause if the death classification was recorded as 'Fatal PE'. A participant was considered to have died from an investigator-assessed VTE-related cause if the investigator's death classification was recorded as 'Fatal PE'. Number of death due to VTE over 10 ± 2 days of treatment were reported.
Up to 12 days
Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment
Time Frame: Up to 12 days
A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. A participant was considered to have had an asymptomatic evaluable venogram if the ICAC answer to the DVT question was 'Yes' or 'No', and to have had an adjudicated asymptomatic DVT if the answer was 'Yes'. The participant was considered to had a proximal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' is 'DVT'. The participant was considered to had a distal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' is 'DVT'.
Up to 12 days
Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment
Time Frame: Up to 12 days
A participant who reported symptoms of DVT was considered to had an adjudicated objectively confirmed symptomatic DVT if the ICAC answer to the question 'Was a symptomatic DVT identified?' was 'Yes' and the event happened no more than 12 days after start of study treatment (unless exemption for extended treatment was granted by the medical monitor) and no more than 1 day after end of study treatment. The participant was considered to had a proximal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' was 'DVT'. The participant was considered to had a distal DVT if either of the investigator's answers to the questions 'Left distal' and 'Right distal' was 'DVT'. Percentage of participants with total symptomatic (distal and proximal) VTE over 10 ± 2 days of treatment were reported.
Up to 12 days
Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up
Time Frame: Up to 68 days
In all participants, additional 3 milliliter of blood was collected at the time of other blood sampling as follow: Baseline, Day 3 (predose, 2, 4, 8, 10, and 12 hours post dose), Day 5 (predose), and Day 10 (predose) or early withdrawal from study medication for the assessment of anti-factor IIa activity. Samples were collected in 3.8% sodium citrate tubes and immediately chilled in ice. Plasma were centrifuged and frozen at approximately -20ºC until time of shipment to the regional central laboratory. Concentration of Trough Anti-IIa Activity over the duration of treatment and follow-up were reported.
Up to 68 days
Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment
Time Frame: Up to 12 days
A participant was included in the ICAC-adjudicated incidence of major bleeding if participant experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Major bleed was defined as clinically overt bleeding, 1) Clinical overt bleeding: clinically apparent bleeding or signs and/or symptoms suggestive of bleeding with confirmatory imaging studies (e.g., ultrasound, computed tomography) 2. Critical Site Involvement: Intracranial, retroperitoneal, intra-ocular, intraspinal, pericardial. 3. Decrease in Hgb > 2 g/dL from baseline, 4. Transfusion of > 2 units of packed RBCs, 5. Medical or Surgical Intervention for the Reported Bleed, 6. Fatal Bleed. If the event satisfied one of the above criteria.
Up to 12 days
Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment
Time Frame: Up to 12 days
A participant was included in the ICAC-adjudicated incidence of major bleeding if experienced an adjudicated major bleed up to 12 days after the start of study treatment and no later than 1 day after end of study treatment. Percentage of participants with VTE and/or major bleeding over 10±2 days of treatment were reported.
Up to 12 days
Percentage of Participants With Total VTE Any Time After Start of Treatment
Time Frame: Up to Visit 9 (Day 28 post treatment)
Participants were assessed for VTE at all study visits and at the end of the study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study were received a mandatory bilateral venogram. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the ICAC-adjudicated incidence of total VTE if experienced any of adjudicated asymptomatic DVT at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or PE at any time during study treatment or death adjudicated to be related to VTE during study treatment. Percentage of participants with total VTE any time after start of treatment were reported.
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
Time Frame: Up to 12 days
The ranges (low concern value; high concern value) for AST (none; > 3 fold upper normal limit (ULN) ), ALT (none; >3 fold ULN), total bilirubin (none; >= 34.2 micromole per litre [umol/L]), Direct bilirubin (none; >= 34.2 umol/L). Percentage of participants with elevated values by 2 fold and 3 fold from ULN any time on-treatment were reported.
Up to 12 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

October 25, 2005

First Submitted That Met QC Criteria

October 26, 2005

First Posted (Estimate)

October 27, 2005

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI101711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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