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NCT03411759: FACIDOCRO
Cytochrome P450's Pharmacogenomics in Chronic Pain Patients
trial in Analgesia in 100 participants. Completed in 23 March 2018.
23 March 2018
Quick facts
| Lead sponsor | University of Bologna |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 8 January 2018 |
| Primary completion | 23 March 2018 |
| Estimated completion | 23 March 2018 |
| Sites | 1 location across Italy |
Conditions studied
- Analgesia — all drugs for Analgesia →
- CYP2D6 Polymorphism — all drugs for CYP2D6 Polymorphism →
- Opioid Use — all drugs for Opioid Use →
- Chronic Pain — all drugs for Chronic Pain →
Sponsor
University of Bologna
Who can join
Adults 18 to 90, any sex, with Analgesia or CYP2D6 Polymorphism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
An Explorative Study of CYP2D6's Polymorphism in a Sample of Chronic Pain Patients.
Fanelli A, Palazzo C, Balzani E, Iuvaro A, et al · · 2020 · cited 1× · PMID 31710684 · DOI 10.1093/pm/pnz265
Verify or expand the search:
- PubMed search for NCT03411759
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03411759 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Bologna
- Last refreshed: 29 March 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03411759.
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