Non-cancerous Chronic Pain Clinical Trial
— AlgoPGxOfficial title:
Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.
| Verified date | February 2023 |
| Source | Centre Hospitalier Universitaire de Nimes |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2023 |
| Est. primary completion date | December 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 - 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 - 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). |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Nimes | Nîmes |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nimes |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 3 | |
| Secondary | 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 | |
| Secondary | 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 2 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Compare clinical therapeutic efficacy between groups | Patient Global Impression of Change (PGIC) score; value between 1-7 | Month 1 | |
| Secondary | Compare clinical therapeutic efficacy between groups | Patient Global Impression of Change (PGIC) score; value between 1-7 | Month 2 | |
| Secondary | Compare clinical therapeutic efficacy between groups | Patient Global Impression of Change (PGIC) score; value between 1-7 | Month 3 | |
| Secondary | Compare patient-reported pain between groups | Visual analog scare 1-10 | Day 0 | |
| Secondary | Compare patient-reported pain between groups | Visual analog scare 1-10 | Week 2 | |
| Secondary | Compare patient-reported pain between groups | Visual analog scare 1-10 | Month 1 | |
| Secondary | Compare patient-reported pain between groups | Visual analog scare 1-10 | Month 2 | |
| Secondary | Compare patient-reported pain between groups | Visual analog scare 1-10 | Month 3 | |
| Secondary | Compare neuropathic pain between groups | DN4 score (Douleur Neuropathique 4 Questions); score between 0-10 | Day 0 | |
| Secondary | Compare neuropathic pain between groups | DN4 score (Douleur Neuropathique 4 Questions); score between 0-10 | Month 1 | |
| Secondary | Compare neuropathic pain between groups | DN4 score (Douleur Neuropathique 4 Questions); score between 0-10 | Month 2 | |
| Secondary | Compare neuropathic pain between groups | DN4 score (Douleur Neuropathique 4 Questions); score between 0-10 | Month 3 | |
| Secondary | Compare benefit/risk ratio of treatment between groups | Overall Benefit of Analgesics Score (OBAS); score between 0-32 | Month 1 | |
| Secondary | Compare benefit/risk ratio of treatment between groups | Overall Benefit of Analgesics Score (OBAS); score between 0-32 | Month 2 | |
| Secondary | Compare benefit/risk ratio of treatment between groups | Overall Benefit of Analgesics Score (OBAS); score between 0-32 | Month 3 | |
| Secondary | Compare quality of life between patients in each group | Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100 | Day 0 | |
| Secondary | Compare quality of life between patients in each group | Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100 | Month 3 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Qualitive comparison of medication compliance between groups | Presence/absence of opioids or metabolites in serum | Month 1 | |
| Secondary | Qualitive comparison of medication compliance between groups | Presence/absence of opioids or metabolites in serum | Month 2 | |
| Secondary | Qualitive comparison of medication compliance between groups | Presence/absence of opioids or metabolites in serum | Month 3 | |
| Secondary | 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 | |
| Secondary | Compare observed medication misuse between groups | Prescription Opioid Misuse Index (POMI) | Month 1 | |
| Secondary | Compare observed medication misuse between groups | Prescription Opioid Misuse Index (POMI) | Month 2 | |
| Secondary | Compare observed medication misuse between groups | Prescription Opioid Misuse Index (POMI) | Month 3 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |