Clinical trial NCT00244725: Odiparcil For The Prevention Of Venous Thromboembolism
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Deep Vein Thrombosis
Fibrillation, Atrial
Venous Thromboembolism
Pulmonary Embolism
Keywords: deep vein thrombosis
total knee replacement
PE
Venous thromboembolism
DVT
pulmonary embolism
VTE
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-10-27
Enrollment: 961
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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:
measure: Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment
timeFrame: Up to 12 days
measure: Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment
timeFrame: Up to 12 days
measure: Percentage of Participants With PE Over 10 ± 2 Days of Treatment
timeFrame: Up to 12 days
measure: Number of Death Due to VTE Over 10 ± 2 Days of Treatment
timeFrame: Up to 12 days
measure: Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment
timeFrame: Up to 12 days
measure: Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment
timeFrame: Up to 12 days
measure: Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up
timeFrame: Up to 68 days
measure: Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment
timeFrame: Up to 12 days
measure: Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment
timeFrame: Up to 12 days
measure: Percentage of Participants With Total VTE Any Time After Start of Treatment
timeFrame: Up to Visit 9 (Day 28 post treatment)
measure: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Banning
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Torrance
country: United States
facility: GSK Investigational Site
state: California
city: Yuba City
country: United States
facility: GSK Investigational Site
state: California
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Lonetree
country: United States
facility: GSK Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Deland
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarsota
country: United States
facility: GSK Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: GSK Investigational Site
state: Florida
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Boise
country: United States
facility: GSK Investigational Site
state: Idaho
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Warren
country: United States
facility: GSK Investigational Site
state: Michigan
city: Mineola
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Allentown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Altoona
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Camp Hill
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Lubbock
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Huntington
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Marshfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Camperdown
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Southport
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Box Hill
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Clayton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Geelong
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Ringwood East
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Windsor
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Ajax
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Don Mills
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: GSK Investigational Site
state: Ontario
city: North York
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Waterloo
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: GSK Investigational Site
state: Prince Edward Island
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Québec
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte Jerome
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Chennai
country: India
facility: GSK Investigational Site
city: Secunderabad
country: India
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Kfar Saba
country: Israel
facility: GSK Investigational Site
city: Petach Tikva
country: Israel
facility: GSK Investigational Site
city: Tel-Aviv
country: Israel
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Klaipeda
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Sosnowiec
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Irkutsk
country: Russian Federation
facility: GSK Investigational Site
city: Kurgan
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Mosocow
country: Russian Federation
facility: GSK Investigational Site
city: Mosocow
country: Russian Federation
facility: GSK Investigational Site
city: Rostov- on- Don
country: Russian Federation
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Centurion
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Cherkasy
country: Ukraine
facility: GSK Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Vinnitsa
country: Ukraine
facility: GSK Investigational Site
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
state: West Midlands
city: Bournmouth
country: United Kingdom
facility: GSK Investigational Site
city: Fife
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Wigan
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: