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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00244725




Registration number
NCT00244725
Ethics application status
Date submitted
25/10/2005
Date registered
27/10/2005
Date last updated
2/05/2017

Titles & IDs
Public title
Odiparcil For The Prevention Of Venous Thromboembolism
Scientific 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
Secondary ID [1] 0 0
ITI101711
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep Vein Thrombosis 0 0
Fibrillation, Atrial 0 0
Venous Thromboembolism 0 0
Pulmonary Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment
Timepoint [1] 0 0
Up to Visit 7 (10 ± 2 days of treatment)
Secondary outcome [1] 0 0
Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment
Timepoint [1] 0 0
Up to 12 days
Secondary outcome [2] 0 0
Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment
Timepoint [2] 0 0
Up to 12 days
Secondary outcome [3] 0 0
Percentage of Participants With PE Over 10 ± 2 Days of Treatment
Timepoint [3] 0 0
Up to 12 days
Secondary outcome [4] 0 0
Number of Death Due to VTE Over 10 ± 2 Days of Treatment
Timepoint [4] 0 0
Up to 12 days
Secondary outcome [5] 0 0
Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment
Timepoint [5] 0 0
Up to 12 days
Secondary outcome [6] 0 0
Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment
Timepoint [6] 0 0
Up to 12 days
Secondary outcome [7] 0 0
Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up
Timepoint [7] 0 0
Up to 68 days
Secondary outcome [8] 0 0
Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment
Timepoint [8] 0 0
Up to 12 days
Secondary outcome [9] 0 0
Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment
Timepoint [9] 0 0
Up to 12 days
Secondary outcome [10] 0 0
Percentage of Participants With Total VTE Any Time After Start of Treatment
Timepoint [10] 0 0
Up to Visit 9 (Day 28 post treatment)
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Up to 12 days

Eligibility
Key inclusion criteria
* Women must be unable to have children.
* Will have a total knee replacement.
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
961
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - Southport
Recruitment hospital [3] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [4] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [5] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [6] 0 0
GSK Investigational Site - Ringwood East
Recruitment hospital [7] 0 0
GSK Investigational Site - Windsor
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
3135 - Ringwood East
Recruitment postcode(s) [7] 0 0
3181 - Windsor
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
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Ohio
Country [16] 0 0
United States of America
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Pennsylvania
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United States of America
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Texas
Country [18] 0 0
United States of America
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Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
West Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Brazil
State/province [21] 0 0
Rio Grande Do Sul
Country [22] 0 0
Canada
State/province [22] 0 0
Manitoba
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Prince Edward Island
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
India
State/province [26] 0 0
Chennai
Country [27] 0 0
India
State/province [27] 0 0
Secunderabad
Country [28] 0 0
Israel
State/province [28] 0 0
Haifa
Country [29] 0 0
Israel
State/province [29] 0 0
Kfar Saba
Country [30] 0 0
Israel
State/province [30] 0 0
Petach Tikva
Country [31] 0 0
Israel
State/province [31] 0 0
Tel-Aviv
Country [32] 0 0
Latvia
State/province [32] 0 0
Riga
Country [33] 0 0
Lithuania
State/province [33] 0 0
Kaunas
Country [34] 0 0
Lithuania
State/province [34] 0 0
Klaipeda
Country [35] 0 0
Lithuania
State/province [35] 0 0
Vilnius
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Poland
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Bialystok
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Poland
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Krakow
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Poland
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Sosnowiec
Country [39] 0 0
Poland
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Wroclaw
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Irkutsk
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Russian Federation
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Kurgan
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Moscow
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Mosocow
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Rostov- on- Don
Country [45] 0 0
South Africa
State/province [45] 0 0
Gauteng
Country [46] 0 0
South Africa
State/province [46] 0 0
Centurion
Country [47] 0 0
South Africa
State/province [47] 0 0
Pretoria
Country [48] 0 0
Ukraine
State/province [48] 0 0
Cherkasy
Country [49] 0 0
Ukraine
State/province [49] 0 0
Dnepropetrovsk
Country [50] 0 0
Ukraine
State/province [50] 0 0
Kyiv
Country [51] 0 0
Ukraine
State/province [51] 0 0
Vinnitsa
Country [52] 0 0
United Kingdom
State/province [52] 0 0
West Midlands
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United Kingdom
State/province [53] 0 0
Bournmouth
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United Kingdom
State/province [54] 0 0
Fife
Country [55] 0 0
United Kingdom
State/province [55] 0 0
London
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Wigan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00244725
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00244725