Cytochrome P450's Pharmacogenomics in Chronic Pain Patients

NCT03411759 | Completed

• 1 other identifier: FACIDOCRO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The use of titrated drugs is at the base of a successful antalgic treatment in order to provide both an adequate relief and a satisfactory tolerability profile. These molecules, though, have a varying degree of efficacy in different subjects due to medical and genetic reasons. The latter are mainly represented by cytochrome (CYP) P450, in particular CYP2D6's polymorphisms are responsible for the diversified metabolism of analgesics used in chronic pain treatments. Four main types of enzymatic metabolism make up the population, each one defined by a different CYP2D6 allele: extensive metabolizers, ultra-rapid metabolizers, intermediate metabolizers and poor metabolizers. Moreover, regarding polytherapies, the analgesics' metabolism could be influenced by coadministration of other drugs, thus determining an inhibition or induction of the metabolic enzymes - known as phenocopying - and potentially also a change in the metabolic phenotype itself. The final outcome is the inconstancy of effectiveness and of the risk of developing side effects. The primary objective of this study is to define a genetic pattern for the gene CYP2D6 by assessing the incidence of poor or ultrarapid metabolizers in a population of chronic pain patients. This will also allow to observe phenocopying in the same population. Hence 100 patients diagnosed with chronic pain will be enrolled. The genetic pattern of the gene CYP2D6 of such patients will be examined by taking mouth samples. At the same time parametric tests for paired data to survey the correlations between phenotypical patterns and pharmacological therapies will be conducted.

Conditions

Analgesia; CYP2D6 Polymorphism; Opioid Use; Chronic Pain

Keywords

CYP2D6; Chronic pain; Cytochrome P450; Opioids

Outcome Measures

Primary Outcomes (1)

• Analyzing the genetic pattern of CYP2D6's genes

  Analyzing the genetic pattern of CYP2D6's genes in a population of chronic pain patients who are treated in a pain therapy clinic

  8-10 months

Secondary Outcomes (1)

• Evaluating the incidence of metabolic phenotype's variation

  8-10 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic pain patients who are treated in a pain therapy clinic

You may qualify if:

• Diagnosis of chronic pain

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Andrea Fanelli

Bologna, 40138, Italy

Location

Related Publications (1)

• Fanelli A, Palazzo C, Balzani E, Iuvaro A, Pelotti S, Melotti RM. An Explorative Study of CYP2D6's Polymorphism in a Sample of Chronic Pain Patients. Pain Med. 2020 May 1;21(5):1010-1017. doi: 10.1093/pm/pnz265.

  PMID: 31710684 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

buccal swab

MeSH Terms

Conditions

Agnosia; Chronic Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 26, 2018
• Study Start: January 8, 2018
• Primary Completion: March 23, 2018
• Study Completion: March 23, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)