Cytochrome P450's Pharmacogenomics in Chronic Pain Patients

NCT ID: NCT03411759

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2018-03-23

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of chronic pain

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Andrea Fanelli

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Andrea Fanelli

Bologna, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 31710684 (View on PubMed)

Other Identifiers

FACIDOCRO

Identifier Type: -

Identifier Source: org_study_id