Gastrointestinal NeoplasmsPhase 4ENOXACARENCT02444572
Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox®
A Phase 4 study testing Enoxaparin 4000 IU in people with Gastrointestinal Neoplasms and Thromboembolic Event, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
Trial summary
Prospective, monocentric, randomized, parallel group, rater-blinded study using two formulations of Enoxaparin sodium (ENOXA® vs LOVENOX®) to compare the thromboembolic events (symptomatic and asymptomatic) in patients undergoing gastrointestinal cancer surgery and thromboprophylactic treatment with either Enoxaparin… Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Gastrointestinal Neoplasms, Thromboembolic Event
- What is being tested?
- Enoxaparin 4000 IU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteTunisia
- Study dates
- Oct 2015to 10 Jul 2020
- Phase
- Phase 4
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over 18 years
- Gastrointestinal (GI) Cancer
- Elective or emergency surgery
- Preventive administration of enoxaparin sodium
Who cannot join
- Patients participating in another study
- Unfractionated heparin (UFH) use up to 30 days prior to surgical procedure
- Renal failure with creatinine clearance <30 ml / min
- Known history of peripheral venous thrombosis and/or deep venous thrombosis in the 3 months prior to inclusion
- Pregnant or breastfeeding women or women of childbearing age not using medically accepted contraceptive method
- Anticoagulant use in the 3 months prior to inclusion
- Patients with known haemostatic disorder
- Patients not consenting to participate in the study, or not capable of understanding its objectives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Thromboembolic Events in Patients Undergoing Gastrointestinal Cancer Surgery and Thromboprophylactic Treatment With Two Enoxaparin Formulations (ENOXA® vs Lovenox®)
Prospective, monocentric, randomized, parallel group, rater-blinded study using two formulations of Enoxaparin sodium (ENOXA® vs LOVENOX®) to compare the thromboembolic events (symptomatic and asymptomatic) in patients undergoing gastrointestinal cancer surgery and thromboprophylactic treatment with either Enoxaparin formulations.
The study has a secondary focus as to evaluate the immunogenicity of the two formulations of Enoxaparin through a subgroup analysis.
Study followup duration is up to 30 days post surgical procedure.
- Conditions
- Gastrointestinal Neoplasms, Thromboembolic Event
- Being tested
- Enoxaparin 4000 IU
- Keywords
- Enoxaparin, Immunogenicity
- Medical subject headings
- Gastrointestinal Neoplasms, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin 4000 IUDrug
Also called ENOXA®, LOVENOX®
| Study group | Role | What they receive |
|---|---|---|
| ENOXA® group | Experimental | Patients under ENOXA® 4000 IU according to randomization:
* Administer ENOXA® 4000 IU (Enoxaparin 4000 IU) per day, regardless of the patient's weight at inclusion
* Start injections 12 hours after the surgical procedure
* Administer ENOXA® subcutaneously
* The administration of ENOXA® should be at the same time on a daily basis for 30 successive days as per the american and french clinical guidelines Receives: Drug: Enoxaparin 4000 IU |
| LOVENOX® group | Active comparator | Patients under LOVENOX® 4000 IU according to randomization:
* Administer LOVENOX® 4000 IU (Enoxaparin 4000 IU) per day, regardless of the patient's weight at inclusion
* Start injections 12 hours after the surgical procedure
* Administer LOVENOX® subcutaneously
* The administration of LOVENOX® should be at the same time on a daily basis for 30 successive days as per the american and french clinical guidelines Receives: Drug: Enoxaparin 4000 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of asymptomatic Deep Venous Thrombosis (DVT)
To compare the incidence of asymptomatic DVT, assessed by Echo Doppler of the lower limbs, between the two study treatment arms
Measured: 7 - 10 days postoperative
Secondary outcomes (3)
Incidence of symptomatic thromboembolic events
Compare the incidence of symptomatic DVT and pulmonary embolism (PE) between the two study treatment arms
Measured: 30 days postoperative
Number of adverse events
To compare the safety of both the study of products
Measured: 30 days postoperative
Incidence of both Enoxaparin formulations immunogenicity
To compare the levels of platelet factor 4 (PF4)-Heparin complex antibodies an platelet count between the two study treatment arms
Measured: 0 -10 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chadli DZIRI, MD, Principal investigator, Charles Nicolle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444572
- Sponsor's protocol ID
- ENOXACARE_med14
- Acronym
- ENOXACARE
- Status last verified
- Jul 2021
- First submitted
- 7 May 2015
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dziri C, Ben Hmida W, Dougaz W, Khalfallah M, Samaali I, Jerraya H, Bouasker I, Nouira R. Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial. PLoS One. 2023 Nov 1;18(11):e0293269. doi: 10.1371/journal.pone.0293269. eCollection 2023.
PubMed 37910523
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thromboembolic Events in Patients Undergoing Gastrointestinal Cancer Surgery and Thromboprophylactic Treatment With Two Enoxaparin Formulations (ENOXA® vs Lovenox®)
- ClinicalTrials.gov ID
- NCT02444572
- Acronym / sponsor ID
- ENOXACARE / ENOXACARE_med14
- Conditions
- Gastrointestinal Neoplasms, Thromboembolic Event
- Keywords
- Enoxaparin, Immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Les Laboratoires des Médicaments StérilesIndustry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 14 May 2015 (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.
Prospective, monocentric, randomized, parallel group, rater-blinded study using two formulations of Enoxaparin sodium (ENOXA® vs LOVENOX®) to compare the thromboembolic events (symptomatic and asymptomatic) in patients undergoing gastrointestinal cancer surgery and thromboprophylactic treatment with either Enoxaparin formulations.
The study has a secondary focus as to evaluate the immunogenicity of the two formulations of Enoxaparin through a subgroup analysis.
Study followup duration is up to 30 days post surgical procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENOXA® group | Experimental | Drug: Enoxaparin 4000 IUPatients under ENOXA® 4000 IU according to randomization: * Administer ENOXA® 4000 IU (Enoxaparin 4000 IU) per day, regardless of the patient's weight at inclusion * Start injections 12 hours after the surgical procedure * Administer ENOXA® subcutaneously * The administration of ENOXA® should be at the same time on a daily basis for 30 successive days as per the american and french clinical guidelines |
| LOVENOX® group | Active comparator | Drug: Enoxaparin 4000 IUPatients under LOVENOX® 4000 IU according to randomization: * Administer LOVENOX® 4000 IU (Enoxaparin 4000 IU) per day, regardless of the patient's weight at inclusion * Start injections 12 hours after the surgical procedure * Administer LOVENOX® subcutaneously * The administration of LOVENOX® should be at the same time on a daily basis for 30 successive days as per the american and french clinical guidelines |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female over 18 years
- Gastrointestinal (GI) Cancer
- Elective or emergency surgery
- Preventive administration of enoxaparin sodium
Key exclusion criteria (8 listed)
- Patients participating in another study
- Unfractionated heparin (UFH) use up to 30 days prior to surgical procedure
- Renal failure with creatinine clearance <30 ml / min
- Known history of peripheral venous thrombosis and/or deep venous thrombosis in the 3 months prior to inclusion
- Pregnant or breastfeeding women or women of childbearing age not using medically accepted contraceptive method
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 |
|---|---|---|
| Enoxaparin 4000 IUAlso: ENOXA®, LOVENOX® | Drug | ENOXA® group, LOVENOX® group |
Primary outcome
Incidence of asymptomatic Deep Venous Thrombosis (DVT)
Time frame: 7 - 10 days postoperative
To compare the incidence of asymptomatic DVT, assessed by Echo Doppler of the lower limbs, between the two study treatment arms
3 secondary outcomes
Incidence of symptomatic thromboembolic events
Time frame: 30 days postoperative
Number of adverse events
Time frame: 30 days postoperative
Incidence of both Enoxaparin formulations immunogenicity
Time frame: 0 -10 days postoperative
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 29 Jul 2021.
- Derived from this study: PubMed 37910523Dziri C, Ben Hmida W, Dougaz W, Khalfallah M, Samaali I, Jerraya H, Bouasker I, Nouira R. Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial. PLoS One. 2023 Nov 1;18(11):e0293269. doi: 10.1371/journal.pone.0293269. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Chadli DZIRI, MD principal investigator
Charles Nicolle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin 4000 IU in people with Gastrointestinal Neoplasms and Thromboembolic Event, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
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 4 inclusion and 8 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 29 Jul 2021. 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 Tunisia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 asymptomatic Deep Venous Thrombosis (DVT) (time frame: 7 - 10 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02444572, which also lists 1 linked publication.
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 29 Jul 2021.