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NCT Number: NCT07384013

Study Protocol: 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)

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Key information

Conditions

Oncologic Diseases Agnosia Cardiovascular Diseases Coagulation Defect Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Metamizole

Drug

chronic metamizole use

Other names: OPTALGIN

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Liat Rappaport

CONTACT

[email protected]

+97247776234

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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