ThromboembolismPhase 3NCT00328939
ARIXTRA Local Study For Registration In China.
A Phase 3 study testing ARIXTRA infusion and Enoxaparine infusion in people with Thromboembolism and Knee Replacement, run by GlaxoSmithKline at 7 sites in China.
Trial summary
This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thromboembolism, Knee Replacement, Hip Replacement
- What is being tested?
- ARIXTRA infusion and Enoxaparine infusion
- Type of treatment
- Injection or infusion
- How many people
- 240 participants
- Where
- 7 sitesChina
- Study dates
- May 2004to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing either an elective major hip or knee replacement or revision.
- Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child.
Who cannot join
- History of serious active bleeding in last 3 month
- Concurrent or history of thrombocytopenia ( Platelet< 100x109/L)
- History of hypersensitivity reaction to heparin, Low molecular weight heparin or pork product
- Acute bacterial endocarditis
- Congenital or acquired bleeding disease in last 3 months
- Concurrent uncontrolled ulcer or gastrointestinal disease with blood vessel dysplasia
Show all 12Show fewer
- Concurrent hemorrhagic cerebrovascular disease or surgical history in cerebral, spine or eye
- Conditions need to leave a tubule in intradural or extradural
- Contraindication to anticoagulant or condition required to take long term oral anticoagulant
- Abnormality in hepatic (>1.5x UNL), renal (Clcr < 30ml/min) or cardiac function, uncontrolled hypertension or tumor Concurrent disorder of blood vessel in lower limb
- Positive result in Human Chorionic Gonadotropin test Participated in any other investigational study on Deep Vein Thrombosis prevention in last 90 days.
- Concurrently to have hip and knee or double hip/knee replacement at the same time
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
GSK Investigational Site
Beijing, 100044
GSK Investigational Site
Chengdu, Sichuan, 610041
GSK Investigational Site
Hangzhou, Zhejiang, 310009
GSK Investigational Site
Qingdao, Shandong, 266001
GSK Investigational Site
Shanghai, 200025
GSK Investigational Site
Xi'an, Shaanxi, 710032
GSK Investigational Site
Zhengzhou, Henan, 450052
About this study
Official title: Randomized, Single Blind, Parallel Study to Compare the Safety and Efficacy of ARIXTRA to Enoxaparine in Patients Undergoing Elective Major Hip or Knee Replacement or a Revision of Components.
This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.
- Conditions
- Thromboembolism, Knee Replacement, Hip Replacement
- Being tested
- ARIXTRA infusion, Enoxaparine infusion
- Keywords
- ARIXTRA, prevention of DVT
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARIXTRA infusionDrug
Enoxaparine infusionDrug
Also called ARIXTRA infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
Secondary outcomes (1)
Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328939
- Sponsor's protocol ID
- ITI105316
- Status last verified
- Feb 2011
- First submitted
- 22 May 2006
- Last updated
- 4 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single Blind, Parallel Study to Compare the Safety and Efficacy of ARIXTRA to Enoxaparine in Patients Undergoing Elective Major Hip or Knee Replacement or a Revision of Components.
- ClinicalTrials.gov ID
- NCT00328939
- Acronym / sponsor ID
- ITI105316
- Conditions
- Thromboembolism, Knee Replacement, Hip Replacement
- Keywords
- ARIXTRA, prevention of DVT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2004
- First posted
- 24 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing either an elective major hip or knee replacement or revision.
- Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child.
Key exclusion criteria (12 listed)
- History of serious active bleeding in last 3 month
- Concurrent or history of thrombocytopenia ( Platelet< 100x109/L)
- History of hypersensitivity reaction to heparin, Low molecular weight heparin or pork product
- Acute bacterial endocarditis
- Congenital or acquired bleeding disease in last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARIXTRA infusion | Drug | – |
| Enoxaparine infusionAlso: ARIXTRA infusion | Drug | – |
Primary outcome
Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
1 secondary outcome
Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ARIXTRA infusion and Enoxaparine infusion in people with Thromboembolism and Knee Replacement, run by GlaxoSmithKline at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2012.