Venous ThromboembolismPhase 3NCT00333021
Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients
A Phase 3 study testing Fondaparinux sodium and GSK576428 in people with Venous Thromboembolism, run by GlaxoSmithKline at 18 sites in Japan.
Trial summary
This study is phase 3 study for prevention of VTE in patients with abdominal surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Fondaparinux sodium and GSK576428
- How many people
- 127 participants
- Where
- 18 sitesJapan
- Study dates
- May 2006to Feb 2007
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged >=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
- General or urologic surgery
- Cancer surgery
- Gynecologic surgery
- Radical surgery for pelvic malignancy
Who cannot join
- Active, clinically significant bleeding Thrombocytopenia Body weight <40kg
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
GSK Investigational Site
Hiroshima, 737-0811
GSK Investigational Site
Hokkaido, 060-0061
GSK Investigational Site
Hokkaido, 060-8543
GSK Investigational Site
Hokkaido, 073-0164
GSK Investigational Site
Hyōgo, 655-0004
GSK Investigational Site
Ibaraki, 300-0053
GSK Investigational Site
Kagawa, 760-0017
GSK Investigational Site
Kagoshima, 890-0061
GSK Investigational Site
Kagoshima, 892-8580
GSK Investigational Site
Nara, 630-0227
GSK Investigational Site
Osaka, 540-0006
GSK Investigational Site
Osaka, 560-0055
GSK Investigational Site
Osaka, 565-0871
GSK Investigational Site
Osaka, 589-8511
GSK Investigational Site
Osaka, 590-0132
GSK Investigational Site
Osaka, 598-0048
GSK Investigational Site
Saitama, 351-0102
GSK Investigational Site
Tokyo, 152-0021
About this study
Official title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism (VTE) After Abdominal Surgery
This study is phase 3 study for prevention of VTE in patients with abdominal surgery.
- Conditions
- Venous Thromboembolism
- Being tested
- Fondaparinux sodium, GSK576428
- Keywords
- Fondaparinux Abdominal surgery Japanese VTE
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fondaparinux sodiumDrug
GSK576428Drug
Also called Fondaparinux sodium
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Venous thromboembolism and Major bleeding
Measured: Throughout entire study
Secondary outcomes (1)
Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism
Measured: Throughout entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startMay 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous 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
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333021
- Sponsor's protocol ID
- AR3106116
- Status last verified
- Jul 2009
- First submitted
- 1 Jun 2006
- Last updated
- 10 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism (VTE) After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00333021
- Acronym / sponsor ID
- AR3106116
- Conditions
- Venous Thromboembolism
- Keywords
- Fondaparinux Abdominal surgery Japanese VTE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 2 Jun 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 study is phase 3 study for prevention of VTE in patients with abdominal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged >=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
- General or urologic surgery
- Cancer surgery
- Gynecologic surgery
- Radical surgery for pelvic malignancy
Key exclusion criteria (1 listed)
- Active, clinically significant bleeding Thrombocytopenia Body weight <40kg
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 |
|---|---|---|
| Fondaparinux sodium | Drug | – |
| GSK576428Also: Fondaparinux sodium | Drug | – |
Primary outcome
Incidence of Venous thromboembolism and Major bleeding
Time frame: Throughout entire study
1 secondary outcome
Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism
Time frame: Throughout entire study
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 10 Jul 2009.
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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, MD study director
GlaxoSmithKline
18 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 Fondaparinux sodium and GSK576428 in people with Venous Thromboembolism, run by GlaxoSmithKline at 18 sites in Japan.
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 5 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 10 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Japan. 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?
Incidence of Venous thromboembolism and Major bleeding (time frame: Throughout entire study). 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 10 Jul 2009.