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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
Assessment method [1] 0 0
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 Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography.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.
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
Assessment method [1] 0 0
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.
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
Assessment method [2] 0 0
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'.
Timepoint [2] 0 0
Up to 12 days
Secondary outcome [3] 0 0
Percentage of Participants With PE Over 10 ± 2 Days of Treatment
Assessment method [3] 0 0
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.
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
Assessment method [4] 0 0
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.
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
Assessment method [5] 0 0
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'.
Timepoint [5] 0 0
Up to 12 days
Secondary outcome [6] 0 0
Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment
Assessment method [6] 0 0
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.
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
Assessment method [7] 0 0
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.
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
Assessment method [8] 0 0
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.
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
Assessment method [9] 0 0
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.
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
Assessment method [10] 0 0
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.
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
Assessment method [11] 0 0
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.
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
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
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
Country [36] 0 0
Poland
State/province [36] 0 0
Bialystok
Country [37] 0 0
Poland
State/province [37] 0 0
Krakow
Country [38] 0 0
Poland
State/province [38] 0 0
Sosnowiec
Country [39] 0 0
Poland
State/province [39] 0 0
Wroclaw
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Irkutsk
Country [41] 0 0
Russian Federation
State/province [41] 0 0
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
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Bournmouth
Country [54] 0 0
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00244725