Cytochrome P450's Pharmacogenomics in Chronic Pain Patients

Chronic Pain Clinical Trial

— FACIDOCRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411759
• Other study ID #: FACIDOCRO
• Status: Completed
• First received: January 17, 2018
• Last updated: March 26, 2018
• Start date: January 8, 2018
• Est. completion date: March 23, 2018

Study information

• Verified date: January 2018
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 23, 2018
• Est. primary completion date: March 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Diagnosis of chronic pain

Exclusion Criteria:

Related Conditions & MeSH terms

• Analgesia
• Chronic Pain
• CYP2D6 Polymorphism
• Opioid Use

Locations

Country	Name	City	State
Italy	Andrea Fanelli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluating the incidence of metabolic phenotype's variation	Evaluating the incidence of metabolic phenotype's variation (phenocopying) in a population of chronic pain patients who are treated in a pain therapy clinic	8-10 months