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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03411759
Other study ID # FACIDOCRO
Secondary ID
Status Completed
Phase
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
Health authority
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:

Study Design


Related Conditions & MeSH terms


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
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