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

NCT05657704 | Unknown Phase 4

• 1 other identifier: 2022-500377-13-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Post-surgical Pain; Pain, Acute; Postoperative Pain

Keywords

Pharmacogenetics; Therapeutic techniques in treatment of acute postoperative pain

Outcome Measures

Primary Outcomes (1)

• Efficacy: analgesic effect (Pain assessment) 4 hours after treatment

  To evaluate the analgesic effect (pain assessment) that will be evaluated throughout visual analogical scale (VAS) from 0 to 100.

  4 hour after treatment

Secondary Outcomes (4)

• Efficacy at the end of treatment

  3 days after treatment administration (72 Hours)

• Correlation between efficacy and the pharmacokinetic parameters (AUC)

  1 hours, 2 hours and 4 hours

• Correlation between efficacy and pharmacogenetic profile (focus in CYP2D6)

  Through study completion, an average of 1 year and 6 months

• Safety evaluations

  Through study completion, an average of 1 year and 6 months

Study Arms (3)

Tramadol

NO INTERVENTION

Patients treated with Tramadol, 100 mg every 8 hours according to clinical practice for the treatment of postoperative pain.

Dexketoprofen

NO INTERVENTION

Patients treated with Dexketoprofen 25 mg every 8 hours according to clinical practice for the treatment of postoperative pain.

Experimental Group

EXPERIMENTAL

The patients in this group will be genotyped before surgery and 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

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

Interventions

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

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

Also known as: Tramadol 100 mg, Tramadol 50 mg, Dexketoprofen 25 mg

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women over 18 years of age.
• Patients scheduled for outpatient surgical extraction, under local anesthesia, of at least two impacted third molars, at least one of which will require bone removal.
• Patients who agree to participate in the study and give written consent.

You may not qualify if:

• Patients under treatment with other drugs that can inhibit CYP2D6, or are contraindicated in combination with tramadol or dexketoprofen.
• Patients on treatment with bisphosphonates.
• Patients who are receiving analgesic treatment before the operation, 24 hours prior to the operation. This criterion will be evaluated at the intervention visit.
• Patients suffering from other uncontrolled diseases.
• Pregnant or breastfeeding women.
• Patients with contraindications for treatment with tramadol or dexketoprofen.

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead
• Hospital Universitario La Paz: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital Universitario Fundación Jiménez Díaz: collaborator
• Hospital Universitario San Juan de Alicante: collaborator
• Hospital Universitario de Burgos: collaborator
• Hospital San Carlos, Madrid: collaborator
• Puerta de Hierro University Hospital: collaborator

Study Sites (8)

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28220, Spain

ACTIVE NOT RECRUITING

Hospital Universitario San Juan de Alicante

Alicante, 03550, Spain

ACTIVE NOT RECRUITING

Hospital General Universitario de Burgos y Clínica Colina

Burgos, 09006, Spain

RECRUITING

Fundación para la Investigación Biomédica Hospital La Princesa

Madrid, 28006, Spain

RECRUITING

Hospital Univesitario Ramón y Cajal

Madrid, 28034, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

ACTIVE NOT RECRUITING

Hostpital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitaro La Paz

Madrid, 28046, Spain

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Tramadol; dexketoprofen trometamol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Central Study Contacts

Francisco Abad Santos, MD

CONTACT

+34915202593; francisco.abad@salud.madrid.org

Jesus Novalbos Reina, PhD

CONTACT

+34915202540; jnovalbos@iis-princesa.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase IV trial and low intervention, multicenter study. Group 1: Tramadol, 100 mg according to clinical practice for the treatment of postoperative pain. Group 2: Dexketoprofen 25 mg according to clinical practice for the treatment of postoperative pain. Experimental group 3: patients in this group will be genotyped before surgery and 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 and Intermediate and poor metabolizers (IM/PM): dexketoprofen 25 mg every 8 hours

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: December 20, 2022
• Study Start: October 5, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)