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

NCT07384013 | Recruiting

• 1 other identifier: 0268-25-RMB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Direct Oral Anticoagulants (DOACs); Optalgin

Outcome Measures

Primary Outcomes (1)

• Change in DOAC

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

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

Study Arms (2)

Cohort 1: Chronic metamizole users

EXPERIMENTAL

Patients receiving Optalgin prior to study enrollment

Drug: metamizole

Cohort 2: New metamizole users

EXPERIMENTAL

Patients receiving Optalgin after to study enrollment

Drug: metamizole

Interventions

metamizole DRUG

chronic metamizole use

Also known as: OPTALGIN

Cohort 1: Chronic metamizole users; Cohort 2: New metamizole users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Hemostatic Disorders; Agnosia

Interventions

Dipyrone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Liat Rappaport

CONTACT

+97247776234; o_trials@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: February 3, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 3, 2026

Record last verified: 2025-12

Locations

IL (1)