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ACTIVE NOT RECRUITING
NCT05657704
PHASE4

Utility of CYP2D6 Genotyping to Improve the Efficacy and Safety of Tramadol

Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

View on ClinicalTrials.gov

Summary

Randomized clinical trial to evaluate the utility of CYP2D6 genotyping to improve the efficacy and safety of tramadol in the treatment of acute postoperative pain. Phase IV and low-intervention trial To evaluate if the implementation of pharmacogenetics in clinical practice can help to improve the treatment of acute pain, increasing efficacy and reducing adverse reactions. The main evaluation variable: This is a simple study, which does not differ from standard clinical practice and therefore we do not expect early ending of the study.

Official title: Randomized Clinical Trial to Evaluate the Utility of CYP2D6 Genotyping to Improve the Efficacy and Safety of Tramadol in the Treatment of Acute Postoperative Pain.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2022-10-05

Completion Date

2026-08-31

Last Updated

2026-08-19

Healthy Volunteers

Yes

Interventions

DRUG

The patients in experimental group will be genotyped before surgery and treatment will be prescribed according to the CYP2D6 phenotype

Treatment will be prescribed according to the CYP2D6 phenotype. Normal Metabolizers (NM): Tramadol 100 mg every 8 hour; Ultrarapid Metabolizers (UM): Tramadol 50 mg every 8 hours Intermediate and poor metabolizers (IM/PM): dexketoprofen 25 mg every 8 hours

Locations (8)

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Universitario San Juan de Alicante

Alicante, Spain

Hospital General Universitario de Burgos y Clínica Colina

Burgos, Spain

Fundación para la Investigación Biomédica Hospital La Princesa

Madrid, Spain

Hospital Univesitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Clínico San Carlos

Madrid, Spain

Hostpital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitaro La Paz

Madrid, Spain