Last updated: 11/04/2018 08:27:58
Odiparcil For The Prevention Of Venous Thromboembolism
GSK study ID
ITI101711
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2006-15-09
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
GSK Investigational Site
Phoenix, Arizona, United States, 85023
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
Status
Study Complete
Location
GSK Investigational Site
Sarsota, Florida, United States, 34239
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23249
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78217
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90509
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45242
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75246
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mineola, New York, United States, 11501
Status
Study Complete
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Toledo, Ohio, United States, 43614
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lonetree, Colorado, United States, 80124
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Southport, Queensland, Australia, 4215
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21215-5271
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sainte Jerome, Québec, Canada, J7Z 5T3
Status
Study Complete
Location
GSK Investigational Site
Banning, California, United States, 92220
Status
Study Complete
Location
GSK Investigational Site
Birmingham, West Midlands, United Kingdom, B18 7QH
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sacramento, California, United States, 95817
Status
Study Complete
Location
GSK Investigational Site
Allentown, Pennsylvania, United States, 18103
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27704
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Altoona, Pennsylvania, United States, 16601
Status
Study Complete
Location
GSK Investigational Site
Warren, Michigan, United States, 48089
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bournmouth, United Kingdom, BH7 7DW
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Yuba City, California, United States, 95991
Status
Study Complete
Location
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21209
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ringwood East, Victoria, Australia, 3135
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033
Status
Study Complete
Location
GSK Investigational Site
Charlottetown, Prince Edward Island, Canada, C1A 1L2
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40509
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
Status
Study Complete
Location
GSK Investigational Site
Camp Hill, Pennsylvania, United States, 17011
Status
Study Complete
Location
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23229
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Huntington, West Virginia, United States, 25701
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Study Complete
Location
GSK Investigational Site
Sarasota, Florida, United States, 34239
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21218
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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Access to clinical trial data by researchers
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