The medical condition to be evaluated is the analgesic response of people with chronic low back pain who are going to be treated with opioids, guided by omics sciences (pharmacogenetics, epigenetics and metabolomics).
Conditions
Interventions
Product Name: Morphine
Pharmaceutical Form: Compressed lozenge
INN or Proposed INN: MORPHINE SULFATE
CAS Number: 64-31-3
Other descriptive name: MORPHINE SULFATE
Product Name: Fentanyl
Pharmaceutical
Sponsors
Institute of Health and Biomedical Research of Alicante
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Patients over 18 years of age. 2- Low back pain for more than 6 months, as a model of non-cancer chronic pain. 3- Patients naïve to opioids and who require analgesic treatment with opioids (tramadol, morphine or fentanyl). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: 1- Subjects with some type of cancer or metastatic pain. 2- Subjects with use of drugs or products metabolized by CYP2D6. 3- Presence or history of allergy to analgesics or pain treatment aids. 4- Pregnant women 5- Presence or history of abuse of prohibited substances. 6- Patients with a history of psychiatric disability that the researcher considers clinically significant, and that prevents the patient from granting their consent or interferes with the proper development of the study. 7- Participants in any other trial during the study period or 30 previous days. 8- Patients who deny their informed consent in writing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to understand through pharmacogenetic markers and epigenetic changes, the different response to opioid analgesics appreciated in women.;Secondary Objective: 1. Identify the metabolic profile according to the activity of the CYP2D6 enzyme. 2. Analyze the epigenetic expression of the OPRM1 and COMT genes, based on sex, their genetic variants and analgesic response. 3. Analyze pharmacokinetics (AUC, Cmax) based on sex and analgesic response, determining the plasma concentrations of analgesics (tramadol, morphine or fentanyl) and their active metabolites. 4. Analyze the influence of the hormonal profile and the moment of the menstrual cycle, and its relationship with the analgesic response. 5. Study the influence of gender roles (sociocultural) on the analgesic response.;Primary end point(s): In the first part of the project, we will study the relationship between the analgesic response of patients with chronic pain, and their genetic / epigenetic information for the COMT, OPRM1 and CYP2D6 genes. It is expected to find a lower analgesic response, in women, extreme CYP2D6 phenotypes (slow or ultrafast), which present a higher % of methylation in the OPRM1 (position +117) and COMT genes.;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In the second part of the project, patients will be grouped in a group guided by sex and omics and a control group. The group guided by sex and omics will be treated taking into account their genetic/epigenetic information. The control group will follow the usual treatment. We expect to get better analgesic response in the group guided by sex and genetic/epigenetic information.;Timepoint(s) of evaluation of this end point: At the end of the study, 4 years. | — |
Countries
Spain
Contacts
Public ContactClinical trial area
Institute of Health and Biomedical Research of Alicante
Outcome results
None listed