FACIDOCRO: Cytochrome P450's Pharmacogenomics in Chronic Pain Patients

Sponsor

University of Bologna (Other)

Overall Status

Completed

CT.gov ID

NCT03411759

Collaborator

(none)

100

Enrollment

Location

2.4

Actual Duration (Months)

41.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia CYP2D6 Polymorphism Opioid Use Chronic Pain

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 8, 2018

Actual Primary Completion Date :

Mar 23, 2018

Actual Study Completion Date :

Mar 23, 2018

Outcome Measures

Primary Outcome Measures

Analyzing the genetic pattern of CYP2D6's genes [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 Outcome Measures

Evaluating the incidence of metabolic phenotype's variation [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of chronic pain

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andrea Fanelli	Bologna		Italy	40138

Sponsors and Collaborators

University of Bologna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrea Fanelli, Principal Investigator, University of Bologna

ClinicalTrials.gov Identifier:

NCT03411759

Other Study ID Numbers:

FACIDOCRO

First Posted:

Jan 26, 2018

Last Update Posted:

Mar 29, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Andrea Fanelli, Principal Investigator, University of Bologna

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Mar 29, 2018