Oncologic DiseasesNCT07384013
Study Protocol: Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs
A study testing metamizole in people with Oncologic Diseases and Coagulation Defect, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Diseases, Coagulation Defect, Pain Management
- What is being tested?
- metamizole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult oncology patients (≥18 years old).
- Receiving apixaban or rivaroxaban for anticoagulation.
- New/current metamizole users taking at least 1g TID for pain management.
- Platelets ≥100×10⁹/L
- ECOG PS<3
- Provided informed consent
Who cannot join
- History of allergic reaction to metamizole or DOACs.
- Individuals with significant gastrointestinal disorders that may affect absorption, including (but not limited to) diagnosed bowel obstruction, persistent diarrhea, or the presence of a nasogastric tube (NGT/zonda)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 31096
047776724, g_froumin@rambam.health.gov.il
About this study
Official title: Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs
Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)
Read the detailed description
Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)
- Conditions
- Oncologic Diseases, Coagulation Defect, Pain Management
- Being tested
- metamizole
- Keywords
- Direct Oral Anticoagulants (DOACs), Optalgin
- Medical subject headings
- Hemostatic Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metamizoleDrug
Also called OPTALGIN
chronic metamizole use
metamizoleDrug
New metamizole users
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Chronic metamizole users | Experimental | Patients receiving Optalgin prior to study enrollment Receives: Drug: metamizole |
| Cohort 2: New metamizole users | Experimental | Patients receiving Optalgin after to study enrollment Receives: Drug: metamizole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DOAC
Change in DOAC peak and trough concentrations during periods with and without metamizole comedication (5 different time points).
Measured: 1- Baseline 2- End Of Treatment 3- Day 3 Post treatment 4- Day 5 Post Treatment 5- Day 7 Post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic DiseasesStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384013
- Sponsor's protocol ID
- 0268-25-RMB
- Status last verified
- Dec 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs
- ClinicalTrials.gov ID
- NCT07384013
- Acronym / sponsor ID
- 0268-25-RMB
- Conditions
- Oncologic Diseases, Coagulation Defect, Pain Management
- Keywords
- Direct Oral Anticoagulants (DOACs), Optalgin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- 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.
Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)
Detailed description
Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Chronic metamizole users | Experimental | Drug: metamizolePatients receiving Optalgin prior to study enrollment |
| Cohort 2: New metamizole users | Experimental | Drug: metamizolePatients receiving Optalgin after to study enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult oncology patients (≥18 years old).
- Receiving apixaban or rivaroxaban for anticoagulation.
- New/current metamizole users taking at least 1g TID for pain management.
- Platelets ≥100×10⁹/L
- ECOG PS<3
Key exclusion criteria (2 listed)
- History of allergic reaction to metamizole or DOACs.
- Individuals with significant gastrointestinal disorders that may affect absorption, including (but not limited to) diagnosed bowel obstruction, persistent diarrhea, or the presence of a nasogastric tube (NGT/zonda)
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 |
|---|---|---|
| metamizoleAlso: OPTALGINchronic metamizole use | Drug | Cohort 1: Chronic metamizole users, Cohort 2: New metamizole users |
| metamizoleNew metamizole users | Drug | Cohort 1: Chronic metamizole users, Cohort 2: New metamizole users |
Primary outcome
Change in DOAC
Time frame: 1- Baseline 2- End Of Treatment 3- Day 3 Post treatment 4- Day 5 Post Treatment 5- Day 7 Post treatment
Change in DOAC peak and trough concentrations during periods with and without metamizole comedication (5 different time points).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metamizole in people with Oncologic Diseases and Coagulation Defect, run by Rambam Health Care Campus at 1 site in Israel.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. 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 Israel. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liat Rappaport (+97247776234, o_trials@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DOAC (time frame: 1- Baseline 2- End Of Treatment 3- Day 3 Post treatment 4- Day 5 Post Treatment 5- Day 7 Post treatment). 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 3 Feb 2026.