Utility of CYP2D6 Genotyping to Improve the Efficacy and Safety of Tramadol
NCT ID: NCT05657704
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
300 participants
INTERVENTIONAL
2022-10-05
2023-12-31
Brief Summary
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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.
Detailed Description
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Phase IV and low-intervention trial The main objective is evaluate if the implementation of pharmacogenetics in clinical practice can help to improve the treatment of acute pain, increasing efficacy and reducing adverse reactions. Secondary objectives: 1. To evaluate whether treatment adjusted according to CYP2D6 phenotype can reduce adverse reactions to tramadol in acute postoperative pain. 2. To compare the efficacy and safety of dexketoprofen and tramadol in the treatment of acute postoperative pain. 3. To investigate the influence on analgesic response and the incidence of adverse reactions of polymorphisms of other genes involved in the pharmacokinetics and mechanism of action of dexketoprofen and tramadol, such as: CYP2C9, CYP2C8, CYP2C19, CYP3A4, CYP3A5, CYP2B6, CYP2E1, COMT, ABCB1, SLC22A1, OPRM1 and PTGS2. 4. To evaluate the relationship of tramadol, M1 and dexketoprofen plasma concentrations with response to treatment and the occurrence of adverse reactions.
Inclusion criteria: 1. Men or women over 18 years of age. 2. 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. 3. Patients who agree to participate in the study and give written consent.
Exclusion criteria: 1. Patients under treatment with other drugs that can inhibit CYP2D6, or are contraindicated in combination with tramadol or dexketoprofen. 2. Patients on treatment with bisphosphonates. 3. Patients who are receiving analgesic treatment before the operation, 24 hours prior to the operation. This criterion will be evaluated at the intervention visit. 4. Patients suffering from other uncontrolled diseases. 5. Pregnant or breastfeeding women. 6. Patients with contraindications for treatment with tramadol or dexketoprofen.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tramadol
Patients treated with Tramadol, 100 mg every 8 hours according to clinical practice for the treatment of postoperative pain.
No interventions assigned to this group
Dexketoprofen
Patients treated with Dexketoprofen 25 mg every 8 hours according to clinical practice for the treatment of postoperative pain.
No interventions assigned to this group
Experimental Group
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Hospital Universitario La Paz
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Hospital Universitario Fundación Jiménez Díaz
OTHER
Hospital Universitario San Juan de Alicante
OTHER
Hospital Universitario de Burgos
OTHER
Hospital San Carlos, Madrid
OTHER
Puerta de Hierro University Hospital
OTHER
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Cesar Colina Santamaría
Role: primary
Miriam Saiz Rodríguez, PhD
Role: backup
Jesús Novalbos Reina, PhD
Role: primary
Francisco Abad Santos, MD
Role: backup
Dolores Martinez Pérez, MD
Role: primary
Lucía Llanos Jiménez, MD
Role: backup
Other Identifiers
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2022-500377-13-01
Identifier Type: -
Identifier Source: org_study_id