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

Rambam Health Care Campus30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Oncologic Diseases Coagulation Defect Pain Management

Interventions

metamizoleDRUG

chronic metamizole use

metamizoleDRUG

New metamizole users

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Outcomes

Primary Outcomes

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

Central Contacts

Liat Rappaport

CONTACT

+97247776234 o_trials@rambam.health.gov.il

Data from ClinicalTrials.gov

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