Abdominal NeoplasmsPhase 3NCT00723216
Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery
A Phase 3 study testing enoxaparin and Physical prophylaxis in people with Abdominal Neoplasms, run by Sanofi at 1 site in Japan.
Trial summary
The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Abdominal Neoplasms
- What is being tested?
- enoxaparin and Physical prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2007to Dec 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
- Malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more.
Who cannot join
- surgery under laparoscope and other endoscopic operations
- clinical signs of deep vein thrombosis
- use of non-steroidal anti-inflammatory drugs from surgery completion until initial administration
- severe hepatic disease or renal disease
- women of childbearing potential, pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium (RP54563) 20mg Bid for 14 Days for Prevention of Venous Thromboembolism in Patients With Curative Abdominal Cancer Surgery. Physical Prophylaxis Only Arm [Intermittent Pneumatic Compression (IPC)] Will be Used as an Indicator of Event Rates.
The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.
- Conditions
- Abdominal Neoplasms
- Being tested
- enoxaparin, Physical prophylaxis
- Keywords
- Prevention, venous thromboembolism, curative surgery
- Medical subject headings
- Abdominal Neoplasms, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enoxaparinDrug
20 mg twice a day
Physical prophylaxisOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Enoxaparin Receives: Drug: enoxaparin |
| 2 | Other | Intermittent Pneumatic Compression (IPC) Receives: Other: Physical prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism incidence
Measured: 28 days
Secondary outcomes (1)
Incidence of deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism incidence except patients with thrombus only in muscle veins, and incidence of proximal vein thrombosis
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- International Clinical Development, Clinical Study Director, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723216
- Sponsor's protocol ID
- EFC10094
- Status last verified
- Apr 2010
- First submitted
- 24 Jul 2008
- Last updated
- 5 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium (RP54563) 20mg Bid for 14 Days for Prevention of Venous Thromboembolism in Patients With Curative Abdominal Cancer Surgery. Physical Prophylaxis Only Arm [Intermittent Pneumatic Compression (IPC)] Will be Used as an Indicator of Event Rates.
- ClinicalTrials.gov ID
- NCT00723216
- Acronym / sponsor ID
- EFC10094
- Conditions
- Abdominal Neoplasms
- Keywords
- Prevention, venous thromboembolism, curative surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Jul 2008 (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.
The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: enoxaparinEnoxaparin |
| 2 | Other | Other: Physical prophylaxisIntermittent Pneumatic Compression (IPC) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more.
Key exclusion criteria (5 listed)
- surgery under laparoscope and other endoscopic operations
- clinical signs of deep vein thrombosis
- use of non-steroidal anti-inflammatory drugs from surgery completion until initial administration
- severe hepatic disease or renal disease
- women of childbearing potential, pregnant or lactating.
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 |
|---|---|---|
| enoxaparin20 mg twice a day | Drug | 1 |
| Physical prophylaxis | Other | 2 |
Primary outcome
Venous thromboembolism incidence
Time frame: 28 days
1 secondary outcome
Incidence of deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism incidence except patients with thrombus only in muscle veins, and incidence of proximal vein thrombosis
Time frame: 28 days
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 5 Apr 2010.
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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.
International Clinical Development, Clinical Study Director study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing enoxaparin and Physical prophylaxis in people with Abdominal Neoplasms, run by Sanofi at 1 site 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 1 inclusion and 5 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 5 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Venous thromboembolism incidence (time frame: 28 days). 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 5 Apr 2010.