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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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ITI101711
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Deep Vein Thrombosis
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0
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Fibrillation, Atrial
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0
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Venous Thromboembolism
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0
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Pulmonary Embolism
0
0
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Condition category
Condition code
Cardiovascular
0
0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
0
0
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0
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Clotting disorders
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Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Odiparcil
Treatment: Drugs - Warfarin
Treatment: Drugs - Coumadin
Treatment: Drugs: Odiparcil
Treatment: Drugs: Warfarin
Treatment: Drugs: Coumadin
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment
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Assessment method [1]
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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.
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Timepoint [1]
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Up to Visit 7 (10 ± 2 days of treatment)
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Secondary outcome [1]
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Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 12 days
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Secondary outcome [2]
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Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment
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Assessment method [2]
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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'.
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Timepoint [2]
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Up to 12 days
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Secondary outcome [3]
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Percentage of Participants With PE Over 10 ± 2 Days of Treatment
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 12 days
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Secondary outcome [4]
0
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Number of Death Due to VTE Over 10 ± 2 Days of Treatment
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 12 days
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Secondary outcome [5]
0
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Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment
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Assessment method [5]
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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'.
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Timepoint [5]
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Up to 12 days
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Secondary outcome [6]
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Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment
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Assessment method [6]
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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.
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Timepoint [6]
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Up to 12 days
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Secondary outcome [7]
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Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up
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Assessment method [7]
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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.
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Timepoint [7]
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Up to 68 days
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Secondary outcome [8]
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Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment
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Assessment method [8]
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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.
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Timepoint [8]
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Up to 12 days
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Secondary outcome [9]
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Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment
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Assessment method [9]
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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.
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Timepoint [9]
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Up to 12 days
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Secondary outcome [10]
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Percentage of Participants With Total VTE Any Time After Start of Treatment
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Assessment method [10]
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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.
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Timepoint [10]
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Up to Visit 9 (Day 28 post treatment)
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Secondary outcome [11]
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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
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Assessment method [11]
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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.
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Timepoint [11]
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Up to 12 days
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Eligibility
Key inclusion criteria
- Women must be unable to have children.
- Will have a total knee replacement.
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Minimum age
35
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2006
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Sample size
Target
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Accrual to date
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Final
961
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Camperdown
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Recruitment hospital [2]
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GSK Investigational Site - Southport
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Recruitment hospital [3]
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GSK Investigational Site - Box Hill
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Recruitment hospital [4]
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GSK Investigational Site - Clayton
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Recruitment hospital [5]
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GSK Investigational Site - Geelong
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Recruitment hospital [6]
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GSK Investigational Site - Ringwood East
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Recruitment hospital [7]
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GSK Investigational Site - Windsor
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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4215 - Southport
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3220 - Geelong
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Recruitment postcode(s) [6]
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3135 - Ringwood East
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Recruitment postcode(s) [7]
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3181 - Windsor
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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0
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Arizona
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Idaho
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Kentucky
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Louisiana
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Maryland
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Wisconsin
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Brazil
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Rio Grande Do Sul
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Manitoba
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Quebec
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India
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Chennai
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India
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Secunderabad
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Latvia
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Riga
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Klaipeda
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Vilnius
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Bialystok
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Krakow
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Sosnowiec
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Wroclaw
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Russian Federation
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Irkutsk
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Russian Federation
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Kurgan
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Moscow
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Mosocow
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Rostov- on- Don
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Gauteng
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Centurion
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Pretoria
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Ukraine
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Cherkasy
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Ukraine
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Dnepropetrovsk
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Ukraine
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Kyiv
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Ukraine
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Vinnitsa
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United Kingdom
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West Midlands
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United Kingdom
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Bournmouth
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United Kingdom
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Fife
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United Kingdom
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London
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United Kingdom
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Wigan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00244725
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00244725
Download to PDF