AlgoPGx: Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.
Study Details
Study Description
Brief Summary
The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Prescription as standard
|
Other: Standard opioid prescription
Opioid prescription made without reference to patient genetic profile (tramadol, codeine or oxycodone)
|
| Experimental: Pharmacogenetic-guided prescription
|
Other: Pharmacogenetic analysis allowing personalized opioid prescription
Genotypic of patient to determine optimal opioid treatment (tramadol, codeine or oxycodone)
|
Outcome Measures
Primary Outcome Measures
- Compare presence/absence undesirable events associated to opioid between groups from predefined list [Month 1]
Presence/absence of at least one undesirable event of at least grade 3 according to list in Annex 17.5 of the protocol
- Compare presence/absence undesirable events associated to opioid between groups from predefined list [Month 2]
Presence/absence of at least one undesirable event of at least grade 3 according to list in Annex 17.5 of the protocol
- Compare presence/absence undesirable events associated to opioid between groups from predefined list [Month 3]
Presence/absence of at least one undesirable event of at least grade 3 according to list in Annex 17.5 of the protocol
- Compare presence/absence undesirable events associated to opioid between groups [Month 1]
Presence/absence of at least one undesirable event of at least grade 3 according to Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- Compare presence/absence undesirable events associated to opioid between groups [Month 2]
Presence/absence of at least one undesirable event of at least grade 3 according to Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- Compare presence/absence undesirable events associated to opioid between groups [Month 3]
Presence/absence of at least one undesirable event of at least grade 3 according to Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Secondary Outcome Measures
- Number of undesirable events associated to opioid between groups [Month 1]
Total number of undesirable event of at least grade 3 according to list in protocol
- Number of undesirable events associated to opioid between groups [Month 2]
Total number of undesirable event of at least grade 3 according to list in protocol
- Number of undesirable events associated to opioid between groups [Month 3]
Total number of undesirable event of at least grade 3 according to list in protocol
- Number of undesirable events associated to opioid between groups [Month 1]
Total number of undesirable event of at least grade 3 according to Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- Number of undesirable events associated to opioid between groups [Month 2]
Total number of undesirable event of at least grade 3 according to Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- Number of undesirable events associated to opioid between groups [Month 3]
Total number of undesirable event of at least grade 3 according to Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- Compare clinical therapeutic efficacy between groups [Month 1]
Patient Global Impression of Change (PGIC) score; value between 1-7
- Compare clinical therapeutic efficacy between groups [Month 2]
Patient Global Impression of Change (PGIC) score; value between 1-7
- Compare clinical therapeutic efficacy between groups [Month 3]
Patient Global Impression of Change (PGIC) score; value between 1-7
- Compare patient-reported pain between groups [Day 0]
Visual analog scare 1-10
- Compare patient-reported pain between groups [Week 2]
Visual analog scare 1-10
- Compare patient-reported pain between groups [Month 1]
Visual analog scare 1-10
- Compare patient-reported pain between groups [Month 2]
Visual analog scare 1-10
- Compare patient-reported pain between groups [Month 3]
Visual analog scare 1-10
- Compare neuropathic pain between groups [Day 0]
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
- Compare neuropathic pain between groups [Month 1]
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
- Compare neuropathic pain between groups [Month 2]
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
- Compare neuropathic pain between groups [Month 3]
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
- Compare benefit/risk ratio of treatment between groups [Month 1]
Overall Benefit of Analgesics Score (OBAS); score between 0-32
- Compare benefit/risk ratio of treatment between groups [Month 2]
Overall Benefit of Analgesics Score (OBAS); score between 0-32
- Compare benefit/risk ratio of treatment between groups [Month 3]
Overall Benefit of Analgesics Score (OBAS); score between 0-32
- Compare quality of life between patients in each group [Day 0]
Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100
- Compare quality of life between patients in each group [Month 3]
Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100
- Compare medication compliance between groups [Month 1]
Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
- Compare medication compliance between groups [Month 2]
Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
- Compare medication compliance between groups [Month 3]
Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
- Qualitive comparison of medication compliance between groups [Month 1]
Presence/absence of opioids or metabolites in serum
- Qualitive comparison of medication compliance between groups [Month 2]
Presence/absence of opioids or metabolites in serum
- Qualitive comparison of medication compliance between groups [Month 3]
Presence/absence of opioids or metabolites in serum
- Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS) [Day 0]
Opioids Risk Tool (ORT): scores of 0-3 (low risk), 4-7 (moderate risk), or ≥ 8 (high risk)
- Compare observed medication misuse between groups [Month 1]
Prescription Opioid Misuse Index (POMI)
- Compare observed medication misuse between groups [Month 2]
Prescription Opioid Misuse Index (POMI)
- Compare observed medication misuse between groups [Month 3]
Prescription Opioid Misuse Index (POMI)
- Correlation between predicted phenotype and observed metabolic ratios [Month 1]
Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS)
- Correlation between predicted phenotype and observed metabolic ratios [Month 2]
Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS)
- Correlation between predicted phenotype and observed metabolic ratios [Month 3]
Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS)
- Metabolic profile of patients [Month 1]
Extensive Metaboliser, Intermediate Metaboliser, Poor Metaboliser or Ultra-rapid Metaboliser according to CYP2D6 phenotype and polymorphism of the glucuronyl transferase gene UGT2B7
- Metabolic profile of patients [Month 2]
Extensive Metaboliser, Intermediate Metaboliser, Poor Metaboliser or Ultra-rapid Metaboliser according to CYP2D6 phenotype and polymorphism of the glucuronyl transferase gene UGT2B7
- Metabolic profile of patients [Month 3]
Extensive Metaboliser, Intermediate Metaboliser, Poor Metaboliser or Ultra-rapid Metaboliser according to CYP2D6 phenotype and polymorphism of the glucuronyl transferase gene UGT2B7
- Correlation between saliva and plasma concentration of opioids [Month 1]
Concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
- Correlation between saliva and plasma concentration of opioids [Month 2]
Concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
- Correlation between saliva and plasma concentration of opioids [Month 3]
Concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The patient must have given their free and informed consent and signed the consent form
-
The patient must be a member or beneficiary of a health insurance plan
-
The patient is at least 18 years old
-
The patient will be available for all visits
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Patients suffer from non-cancerous chronic pain according to HAS criteria
-
Patient not having taking opioids in previous 2 months
-
Patient indicated for prescription of opioids (oxycodone, codeine or tramadol) or patient not responding to first line treatment
Exclusion Criteria:
-
The subject is participating in an category I interventional study, or is in a period of exclusion determined by a previous study
-
The subject refuses to sign the consent
-
It is impossible to give the subject informed information
-
The patient is under safeguard of justice or state guardianship
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The patient is pregnant or breastfeeding
-
The patient is likely to procreate and does not use an effective method of contraception (contraceptive ring, surgical contraception, implant, patch, contraceptive pill, male and female condoms, IUD)
-
There is a contra-indication for opioid use
-
Patient with an addiction risk (score ≥ 8 on ORT scale).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Nimes | Nîmes | France | 30029 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Jean-Christophe Boyer, CHU Nimes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NIMAO/2017-02/JCB-01