NCT03498014
Withdrawn
N/A
Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.
Centre Hospitalier Universitaire de Nīmes1 site in 1 countryJuly 2022
ConditionsNon-cancerous Chronic Pain
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Non-cancerous Chronic Pain
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Locations
- 1
- Primary Endpoint
- Compare presence/absence undesirable events associated to opioid between groups from predefined list
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility 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
- •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).
Outcomes
Primary Outcomes
Compare presence/absence undesirable events associated to opioid between groups from predefined list
Time Frame: 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
Time Frame: 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 Outcomes
- Compare observed medication misuse between groups(Month 3)
- Number of undesirable events associated to opioid between groups(Month 3)
- Compare benefit/risk ratio of treatment between groups(Month 3)
- Compare quality of life between patients in each group(Month 3)
- Qualitive comparison of medication compliance between groups(Month 3)
- Compare patient-reported pain between groups(Month 3)
- Compare neuropathic pain between groups(Month 3)
- Correlation between predicted phenotype and observed metabolic ratios(Month 3)
- Metabolic profile of patients(Month 3)
- Correlation between saliva and plasma concentration of opioids(Month 3)
- Compare medication compliance between groups(Month 3)
- Compare clinical therapeutic efficacy between groups(Month 3)
- Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)(Day 0)
Study Sites (1)
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