ThromboembolismNCT01420809
Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection
An observational study of Thromboembolism, run by GlaxoSmithKline.
Trial summary
This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thromboembolism
- How many people
- 1,280 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Aug 2009
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism
Who may be able to join
- Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism
Who cannot join
- Not applicable
About this study
This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism.
(ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)
- Conditions
- Thromboembolism
- Medical subject headings
- Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb
Measured: 3 months
Occurrence of adverse events of bleeding
Measured: 3 months
Presence or absence of venous thromboembolism after treatment of fondaparinux
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startSep 2007
- Primary completionMay 2009
- Study completionAug 2009
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,280 participants (actual)
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
- NCT01420809
- Sponsor's protocol ID
- 112285
- Status last verified
- May 2017
- First submitted
- 28 Jul 2011
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection
- ClinicalTrials.gov ID
- NCT01420809
- Acronym / sponsor ID
- 112285
- Conditions
- Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,280 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Aug 2011 (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 post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism.
(ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism
Key inclusion criteria (1 listed)
- Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb
Time frame: 3 months
Occurrence of adverse events of bleeding
Time frame: 3 months
Presence or absence of venous thromboembolism after treatment of fondaparinux
Time frame: 3 months
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 16 May 2017.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism, run by GlaxoSmithKline.
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 1 inclusion and 1 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 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb (time frame: 3 months). The study lists 3 primary outcomes in all. 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 16 May 2017.