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

NCT07384013 · tracked via the Priya Life Science Israel tracker

Sponsor

Rambam Health Care Campus

Phase

Not applicable

Started

2025-11-01

Last updated

2026-02-03

Condition(s) studied

Oncologic DiseasesCoagulation DefectPain Management

Investigational drug(s) / intervention(s)

metamizole →metamizole →

metamizole: chronic metamizole use

metamizole: New metamizole users

Study summary

Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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. * Platelets ≥100×10⁹/L * ECOG PS\<3 * Provided informed consent 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)

Primary outcome measure(s)

Change in DOAC — 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).

Trial sites (1)

Facility	City	Region	Status
Rambam Health Care Campus	Haifa	Israel	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07384013 on ClinicalTrials.gov ↗ ← All trials in Israel