Back to resultsComparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain. (AlgoPGx)
Primary Purpose
Non-cancerous Chronic Pain
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pharmacogenetic analysis allowing personalized opioid prescription
Standard opioid prescription
Sponsored by
About this trial
This is an interventional treatment trial for Non-cancerous Chronic Pain
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).
Sites / Locations
- CHU Nimes
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Prescription as standard
Pharmacogenetic-guided prescription
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
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)
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)
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)
Secondary Outcome Measures
Number of undesirable events associated to opioid between groups
Total number of undesirable event of at least grade 3 according to list in protocol
Number of undesirable events associated to opioid between groups
Total number of undesirable event of at least grade 3 according to list in protocol
Number of undesirable events associated to opioid between groups
Total number of undesirable event of at least grade 3 according to list in protocol
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)
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)
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)
Compare clinical therapeutic efficacy between groups
Patient Global Impression of Change (PGIC) score; value between 1-7
Compare clinical therapeutic efficacy between groups
Patient Global Impression of Change (PGIC) score; value between 1-7
Compare clinical therapeutic efficacy between groups
Patient Global Impression of Change (PGIC) score; value between 1-7
Compare patient-reported pain between groups
Visual analog scare 1-10
Compare patient-reported pain between groups
Visual analog scare 1-10
Compare patient-reported pain between groups
Visual analog scare 1-10
Compare patient-reported pain between groups
Visual analog scare 1-10
Compare patient-reported pain between groups
Visual analog scare 1-10
Compare neuropathic pain between groups
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Compare neuropathic pain between groups
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Compare neuropathic pain between groups
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Compare neuropathic pain between groups
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Compare benefit/risk ratio of treatment between groups
Overall Benefit of Analgesics Score (OBAS); score between 0-32
Compare benefit/risk ratio of treatment between groups
Overall Benefit of Analgesics Score (OBAS); score between 0-32
Compare benefit/risk ratio of treatment between groups
Overall Benefit of Analgesics Score (OBAS); score between 0-32
Compare quality of life between patients in each group
Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100
Compare quality of life between patients in each group
Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100
Compare medication compliance between groups
Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Compare medication compliance between groups
Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Compare medication compliance between groups
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
Presence/absence of opioids or metabolites in serum
Qualitive comparison of medication compliance between groups
Presence/absence of opioids or metabolites in serum
Qualitive comparison of medication compliance between groups
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)
Opioids Risk Tool (ORT): scores of 0-3 (low risk), 4-7 (moderate risk), or ≥ 8 (high risk)
Compare observed medication misuse between groups
Prescription Opioid Misuse Index (POMI)
Compare observed medication misuse between groups
Prescription Opioid Misuse Index (POMI)
Compare observed medication misuse between groups
Prescription Opioid Misuse Index (POMI)
Correlation between predicted phenotype and observed metabolic ratios
Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS)
Correlation between predicted phenotype and observed metabolic ratios
Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS)
Correlation between predicted phenotype and observed metabolic ratios
Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS)
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
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
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
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)
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)
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)
Full Information
NCT ID
NCT03498014
First Posted
March 29, 2018
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT03498014
Brief Title
Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.
Acronym
AlgoPGx
Official Title
Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
no started
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-cancerous Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prescription as standard
Arm Type
Active Comparator
Arm Title
Pharmacogenetic-guided prescription
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pharmacogenetic analysis allowing personalized opioid prescription
Intervention Description
Genotypic of patient to determine optimal opioid treatment (tramadol, codeine or oxycodone)
Intervention Type
Other
Intervention Name(s)
Standard opioid prescription
Intervention Description
Opioid prescription made without reference to patient genetic profile (tramadol, codeine or oxycodone)
Primary Outcome Measure Information:
Title
Compare presence/absence undesirable events associated to opioid between groups from predefined list
Description
Presence/absence of at least one undesirable event of at least grade 3 according to list in Annex 17.5 of the protocol
Time Frame
Month 1
Title
Compare presence/absence undesirable events associated to opioid between groups from predefined list
Description
Presence/absence of at least one undesirable event of at least grade 3 according to list in Annex 17.5 of the protocol
Time Frame
Month 2
Title
Compare presence/absence undesirable events associated to opioid between groups from predefined list
Description
Presence/absence of at least one undesirable event of at least grade 3 according to list in Annex 17.5 of the protocol
Time Frame
Month 3
Title
Compare presence/absence undesirable events associated to opioid between groups
Description
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)
Time Frame
Month 1
Title
Compare presence/absence undesirable events associated to opioid between groups
Description
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)
Time Frame
Month 2
Title
Compare presence/absence undesirable events associated to opioid between groups
Description
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)
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Number of undesirable events associated to opioid between groups
Description
Total number of undesirable event of at least grade 3 according to list in protocol
Time Frame
Month 1
Title
Number of undesirable events associated to opioid between groups
Description
Total number of undesirable event of at least grade 3 according to list in protocol
Time Frame
Month 2
Title
Number of undesirable events associated to opioid between groups
Description
Total number of undesirable event of at least grade 3 according to list in protocol
Time Frame
Month 3
Title
Number of undesirable events associated to opioid between groups
Description
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)
Time Frame
Month 1
Title
Number of undesirable events associated to opioid between groups
Description
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)
Time Frame
Month 2
Title
Number of undesirable events associated to opioid between groups
Description
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)
Time Frame
Month 3
Title
Compare clinical therapeutic efficacy between groups
Description
Patient Global Impression of Change (PGIC) score; value between 1-7
Time Frame
Month 1
Title
Compare clinical therapeutic efficacy between groups
Description
Patient Global Impression of Change (PGIC) score; value between 1-7
Time Frame
Month 2
Title
Compare clinical therapeutic efficacy between groups
Description
Patient Global Impression of Change (PGIC) score; value between 1-7
Time Frame
Month 3
Title
Compare patient-reported pain between groups
Description
Visual analog scare 1-10
Time Frame
Day 0
Title
Compare patient-reported pain between groups
Description
Visual analog scare 1-10
Time Frame
Week 2
Title
Compare patient-reported pain between groups
Description
Visual analog scare 1-10
Time Frame
Month 1
Title
Compare patient-reported pain between groups
Description
Visual analog scare 1-10
Time Frame
Month 2
Title
Compare patient-reported pain between groups
Description
Visual analog scare 1-10
Time Frame
Month 3
Title
Compare neuropathic pain between groups
Description
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Time Frame
Day 0
Title
Compare neuropathic pain between groups
Description
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Time Frame
Month 1
Title
Compare neuropathic pain between groups
Description
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Time Frame
Month 2
Title
Compare neuropathic pain between groups
Description
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Time Frame
Month 3
Title
Compare benefit/risk ratio of treatment between groups
Description
Overall Benefit of Analgesics Score (OBAS); score between 0-32
Time Frame
Month 1
Title
Compare benefit/risk ratio of treatment between groups
Description
Overall Benefit of Analgesics Score (OBAS); score between 0-32
Time Frame
Month 2
Title
Compare benefit/risk ratio of treatment between groups
Description
Overall Benefit of Analgesics Score (OBAS); score between 0-32
Time Frame
Month 3
Title
Compare quality of life between patients in each group
Description
Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100
Time Frame
Day 0
Title
Compare quality of life between patients in each group
Description
Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100
Time Frame
Month 3
Title
Compare medication compliance between groups
Description
Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Time Frame
Month 1
Title
Compare medication compliance between groups
Description
Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Time Frame
Month 2
Title
Compare medication compliance between groups
Description
Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Time Frame
Month 3
Title
Qualitive comparison of medication compliance between groups
Description
Presence/absence of opioids or metabolites in serum
Time Frame
Month 1
Title
Qualitive comparison of medication compliance between groups
Description
Presence/absence of opioids or metabolites in serum
Time Frame
Month 2
Title
Qualitive comparison of medication compliance between groups
Description
Presence/absence of opioids or metabolites in serum
Time Frame
Month 3
Title
Serum concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Description
Opioids Risk Tool (ORT): scores of 0-3 (low risk), 4-7 (moderate risk), or ≥ 8 (high risk)
Time Frame
Day 0
Title
Compare observed medication misuse between groups
Description
Prescription Opioid Misuse Index (POMI)
Time Frame
Month 1
Title
Compare observed medication misuse between groups
Description
Prescription Opioid Misuse Index (POMI)
Time Frame
Month 2
Title
Compare observed medication misuse between groups
Description
Prescription Opioid Misuse Index (POMI)
Time Frame
Month 3
Title
Correlation between predicted phenotype and observed metabolic ratios
Description
Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS)
Time Frame
Month 1
Title
Correlation between predicted phenotype and observed metabolic ratios
Description
Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS)
Time Frame
Month 2
Title
Correlation between predicted phenotype and observed metabolic ratios
Description
Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS)
Time Frame
Month 3
Title
Metabolic profile of patients
Description
Extensive Metaboliser, Intermediate Metaboliser, Poor Metaboliser or Ultra-rapid Metaboliser according to CYP2D6 phenotype and polymorphism of the glucuronyl transferase gene UGT2B7
Time Frame
Month 1
Title
Metabolic profile of patients
Description
Extensive Metaboliser, Intermediate Metaboliser, Poor Metaboliser or Ultra-rapid Metaboliser according to CYP2D6 phenotype and polymorphism of the glucuronyl transferase gene UGT2B7
Time Frame
Month 2
Title
Metabolic profile of patients
Description
Extensive Metaboliser, Intermediate Metaboliser, Poor Metaboliser or Ultra-rapid Metaboliser according to CYP2D6 phenotype and polymorphism of the glucuronyl transferase gene UGT2B7
Time Frame
Month 3
Title
Correlation between saliva and plasma concentration of opioids
Description
Concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Time Frame
Month 1
Title
Correlation between saliva and plasma concentration of opioids
Description
Concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Time Frame
Month 2
Title
Correlation between saliva and plasma concentration of opioids
Description
Concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Time Frame
Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Boyer
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.
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