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Cytochrome P450's Pharmacogenomics in Chronic Pain Patients

Exploratory Study of Cytochrome P450's Pharmacogenomics in Chronic Pain Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03411759
Acronym
FACIDOCRO
Enrollment
100
Registered
2018-01-26
Start date
2018-01-08
Completion date
2018-03-23
Last updated
2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Chronic Pain, CYP2D6 Polymorphism, Opioid Use

Keywords

CYP2D6, Chronic pain, Cytochrome P450, Opioids

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.

Interventions

None listed

Sponsors

University of Bologna
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of chronic pain

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Analyzing the genetic pattern of CYP2D6's genes8-10 monthsAnalyzing the genetic pattern of CYP2D6's genes in a population of chronic pain patients who are treated in a pain therapy clinic

Secondary

MeasureTime frameDescription
Evaluating the incidence of metabolic phenotype's variation8-10 monthsEvaluating the incidence of metabolic phenotype's variation (phenocopying) in a population of chronic pain patients who are treated in a pain therapy clinic

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026