ClinicalTrials.gg
RecruitingNCT07384013Updated Feb 3, 2026

Study Protocol: Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs

An interventional study of metamizole and metamizole in Oncologic Diseases, Coagulation Defect and Pain Management, sponsored by Rambam Health Care Campus. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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)

02

Conditions studied

  • Oncologic Diseases
  • Coagulation Defect
  • Pain Management

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Keywords

  • Direct Oral Anticoagulants (DOACs)
  • Optalgin
03

In context

Hemostatic Disorders

361 studies on the registry are indexed under Hemostatic Disorders; 65 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 171 interventional studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult oncology patients (≥18 years old).
  • Receiving apixaban or rivaroxaban for anticoagulation.
  • New/current metamizole users taking at least 1g TID for pain management.
  • ≥100×10⁹/L
  • PS\<3
  • Provided

Exclusion criteria

Exclusion Criteria:

  • 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)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Cohort 1: Chronic metamizole users

    Patients receiving Optalgin prior to study enrollment

    Drug: metamizole

  • Experimental
    Cohort 2: New metamizole users

    Patients receiving Optalgin after to study enrollment

    Drug: metamizole

Interventions

06

What researchers measure

Primary outcomes

  1. Change in DOAC

    Change in DOAC peak and trough concentrations during periods with and without metamizole comedication (5 different time points).

    Time frame: 1- Baseline 2- End Of Treatment 3- Day 3 Post treatment 4- Day 5 Post Treatment 5- Day 7 Post treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Dec 2027, 25 months after the start.

Of 31 non-industry interventional studies with no phase under Hemostatic Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 25 months is close to that.

Counting every sponsor, half of 33 studies reached it within 22 months; a quarter within 13 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2025
First posted
Feb 3, 2026
StartActual
Nov 1, 2025
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Feb 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07384013
Responsible party
Sponsor
First posted
Feb 3, 2026
Start date
Nov 1, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Feb 3, 2026

Study contacts

Liat Rappaport
Contact
o_trials@rambam.health.gov.il
+97247776234

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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