Last updated: 11/04/2018 07:53:48
Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)
GSK study ID
FTI102595
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
Official title: Dose ranging trial for the evaluation of the safety and efficacy of GW813893 in the prophylaxis of venous thromboembolism post total knee replacement surgery.
Trial description: This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s) and dose regimen of GW813893 for future investigation.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Incidence of death OR symptomatic or non-symptomatic blood clots in the legs OR symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.
Timeframe: symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.
Secondary outcomes:
Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery.
Timeframe: Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery
Interventions:
Drug: GW813893
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Venous thromboembolism
Product
GW813893
Collaborators
None
Study date(s)
March 2007 to June 2008
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 85 Years
Accepts healthy volunteers
No
- Patients who are scheduled for primary elective unilateral total knee arthroplasty.
- Women who are not surgically sterile or post-menopausal
- Have a contra-indication to contract venography
Inclusion and exclusion criteria
Inclusion criteria:
- Patients who are scheduled for primary elective unilateral total knee arthroplasty.
Exclusion criteria:
- Women who are not surgically sterile or post-menopausal
- Have a contra-indication to contract venography
- Have a known disorder associated with increased risk of bleeding or have been immobile up to 12 weeks before surgery.
Trial location(s)
Location
GSK Clinical Trials Call Center
Decatur, GA, United States, 30032
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Phoenix, AZ, United States, 85023
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center`
Phoenix, AZ, United States, 85023
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Charleston, SC, United States, 29414
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Birmingham, AL, United States, 35209
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
San Antonio, TX, United States, 78217
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
St. Petersburg, FL, United States, 33703
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Yuba City, CA, United States, 95991
Status
Will Be Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website