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The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prescription as standard | Active Comparator |
| |
| Pharmacogenetic-guided prescription | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacogenetic analysis allowing personalized opioid prescription | Other | Genotypic of patient to determine optimal opioid treatment (tramadol, codeine or oxycodone) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare presence/absence undesirable events associated to opioid between groups from predefined list | Presence/absence of at least one undesirable event of at least grade 3 according to list in Annex 17.5 of the protocol | Month 1 |
| Compare presence/absence undesirable events associated to opioid between groups from predefined list | Presence/absence of at least one undesirable event of at least grade 3 according to list in Annex 17.5 of the protocol | Month 2 |
| Compare presence/absence undesirable events associated to opioid between groups from predefined list | Presence/absence of at least one undesirable event of at least grade 3 according to list in Annex 17.5 of the protocol | Month 3 |
| Compare presence/absence undesirable events associated to opioid between groups | 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) | Month 1 |
| Compare presence/absence undesirable events associated to opioid between groups | 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) | Month 2 |
| Compare presence/absence undesirable events associated to opioid between groups | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of undesirable events associated to opioid between groups | Total number of undesirable event of at least grade 3 according to list in protocol | Month 1 |
| Number of undesirable events associated to opioid between groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Christophe Boyer | CHU Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nimes | Nîmes | 30029 | France |
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| Standard opioid prescription | Other | Opioid prescription made without reference to patient genetic profile (tramadol, codeine or oxycodone) |
|
| Month 3 |
Total number of undesirable event of at least grade 3 according to list in protocol
| Month 2 |
| Number of undesirable events associated to opioid between groups | Total number of undesirable event of at least grade 3 according to list in protocol | Month 3 |
| Number of undesirable events associated to opioid between groups | 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) | Month 1 |
| Number of undesirable events associated to opioid between groups | 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) | Month 2 |
| Number of undesirable events associated to opioid between groups | 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) | Month 3 |
| Compare clinical therapeutic efficacy between groups | Patient Global Impression of Change (PGIC) score; value between 1-7 | Month 1 |
| Compare clinical therapeutic efficacy between groups | Patient Global Impression of Change (PGIC) score; value between 1-7 | Month 2 |
| Compare clinical therapeutic efficacy between groups | Patient Global Impression of Change (PGIC) score; value between 1-7 | Month 3 |
| Compare patient-reported pain between groups | Visual analog scare 1-10 | Day 0 |
| Compare patient-reported pain between groups | Visual analog scare 1-10 | Week 2 |
| Compare patient-reported pain between groups | Visual analog scare 1-10 | Month 1 |
| Compare patient-reported pain between groups | Visual analog scare 1-10 | Month 2 |
| Compare patient-reported pain between groups | Visual analog scare 1-10 | Month 3 |
| Compare neuropathic pain between groups | DN4 score (Douleur Neuropathique 4 Questions); score between 0-10 | Day 0 |
| Compare neuropathic pain between groups | DN4 score (Douleur Neuropathique 4 Questions); score between 0-10 | Month 1 |
| Compare neuropathic pain between groups | DN4 score (Douleur Neuropathique 4 Questions); score between 0-10 | Month 2 |
| Compare neuropathic pain between groups | DN4 score (Douleur Neuropathique 4 Questions); score between 0-10 | Month 3 |
| Compare benefit/risk ratio of treatment between groups | Overall Benefit of Analgesics Score (OBAS); score between 0-32 | Month 1 |
| Compare benefit/risk ratio of treatment between groups | Overall Benefit of Analgesics Score (OBAS); score between 0-32 | Month 2 |
| Compare benefit/risk ratio of treatment between groups | Overall Benefit of Analgesics Score (OBAS); score between 0-32 | Month 3 |
| Compare quality of life between patients in each group | Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100 | Day 0 |
| Compare quality of life between patients in each group | Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100 | Month 3 |
| Compare medication compliance between groups | Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS) | Month 1 |
| Compare medication compliance between groups | Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS) | Month 2 |
| Compare medication compliance between groups | Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS) | Month 3 |
| Qualitive comparison of medication compliance between groups | Presence/absence of opioids or metabolites in serum | Month 1 |
| Qualitive comparison of medication compliance between groups | Presence/absence of opioids or metabolites in serum | Month 2 |
| Qualitive comparison of medication compliance between groups | Presence/absence of opioids or metabolites in serum | Month 3 |
| Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS) | Opioids Risk Tool (ORT): scores of 0-3 (low risk), 4-7 (moderate risk), or ≥ 8 (high risk) | Day 0 |
| Compare observed medication misuse between groups | Prescription Opioid Misuse Index (POMI) | Month 1 |
| Compare observed medication misuse between groups | Prescription Opioid Misuse Index (POMI) | Month 2 |
| Compare observed medication misuse between groups | Prescription Opioid Misuse Index (POMI) | Month 3 |
| Correlation between predicted phenotype and observed metabolic ratios | Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS) | Month 1 |
| Correlation between predicted phenotype and observed metabolic ratios | Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS) | Month 2 |
| Correlation between predicted phenotype and observed metabolic ratios | Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS) | Month 3 |
| Metabolic profile of patients | Extensive Metaboliser, Intermediate Metaboliser, Poor Metaboliser or Ultra-rapid Metaboliser according to CYP2D6 phenotype and polymorphism of the glucuronyl transferase gene UGT2B7 | Month 1 |
| Metabolic profile of patients | Extensive Metaboliser, Intermediate Metaboliser, Poor Metaboliser or Ultra-rapid Metaboliser according to CYP2D6 phenotype and polymorphism of the glucuronyl transferase gene UGT2B7 | Month 2 |
| Metabolic profile of patients | Extensive Metaboliser, Intermediate Metaboliser, Poor Metaboliser or Ultra-rapid Metaboliser according to CYP2D6 phenotype and polymorphism of the glucuronyl transferase gene UGT2B7 | Month 3 |
| Correlation between saliva and plasma concentration of opioids | Concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS) | Month 1 |
| Correlation between saliva and plasma concentration of opioids | Concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS) | Month 2 |
| Correlation between saliva and plasma concentration of opioids | Concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS) | Month 3 |