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NCT Number: NCT03411759

Cytochrome P450's Pharmacogenomics in Chronic Pain Patients

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Andrea Fanelli

Bologna, 40138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of chronic pain

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Analyzing the genetic pattern of CYP2D6's genes

    Time frame: 8-10 months

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

Secondary outcomes

  1. Evaluating the incidence of metabolic phenotype's variation

    Time frame: 8-10 months

    Evaluating the incidence of metabolic phenotype's variation (phenocopying) in a population of chronic pain patients who are treated in a pain therapy clinic

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Acronym: FACIDOCRO

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2018
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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