Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain. (AlgoPGx)

February 7, 2023 updated by: Centre Hospitalier Universitaire de Nīmes
The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Compare presence/absence undesirable events associated to opioid between groups from predefined list
Time Frame: 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
Month 1
Compare presence/absence undesirable events associated to opioid between groups from predefined list
Time Frame: 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
Month 2
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
Month 3
Compare presence/absence undesirable events associated to opioid between groups
Time Frame: 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)
Month 1
Compare presence/absence undesirable events associated to opioid between groups
Time Frame: 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)
Month 2
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)
Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of undesirable events associated to opioid between groups
Time Frame: Month 1
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
Time Frame: Month 2
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
Time Frame: Month 3
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
Time Frame: 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)
Month 1
Number of undesirable events associated to opioid between groups
Time Frame: 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)
Month 2
Number of undesirable events associated to opioid between groups
Time Frame: 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)
Month 3
Compare clinical therapeutic efficacy between groups
Time Frame: Month 1
Patient Global Impression of Change (PGIC) score; value between 1-7
Month 1
Compare clinical therapeutic efficacy between groups
Time Frame: Month 2
Patient Global Impression of Change (PGIC) score; value between 1-7
Month 2
Compare clinical therapeutic efficacy between groups
Time Frame: Month 3
Patient Global Impression of Change (PGIC) score; value between 1-7
Month 3
Compare patient-reported pain between groups
Time Frame: Day 0
Visual analog scare 1-10
Day 0
Compare patient-reported pain between groups
Time Frame: Week 2
Visual analog scare 1-10
Week 2
Compare patient-reported pain between groups
Time Frame: Month 1
Visual analog scare 1-10
Month 1
Compare patient-reported pain between groups
Time Frame: Month 2
Visual analog scare 1-10
Month 2
Compare patient-reported pain between groups
Time Frame: Month 3
Visual analog scare 1-10
Month 3
Compare neuropathic pain between groups
Time Frame: Day 0
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Day 0
Compare neuropathic pain between groups
Time Frame: Month 1
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Month 1
Compare neuropathic pain between groups
Time Frame: Month 2
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Month 2
Compare neuropathic pain between groups
Time Frame: Month 3
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Month 3
Compare benefit/risk ratio of treatment between groups
Time Frame: Month 1
Overall Benefit of Analgesics Score (OBAS); score between 0-32
Month 1
Compare benefit/risk ratio of treatment between groups
Time Frame: Month 2
Overall Benefit of Analgesics Score (OBAS); score between 0-32
Month 2
Compare benefit/risk ratio of treatment between groups
Time Frame: Month 3
Overall Benefit of Analgesics Score (OBAS); score between 0-32
Month 3
Compare quality of life between patients in each group
Time Frame: Day 0
Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100
Day 0
Compare quality of life between patients in each group
Time Frame: Month 3
Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100
Month 3
Compare medication compliance between groups
Time Frame: Month 1
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
Time Frame: Month 2
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
Time Frame: Month 3
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
Time Frame: Month 1
Presence/absence of opioids or metabolites in serum
Month 1
Qualitive comparison of medication compliance between groups
Time Frame: Month 2
Presence/absence of opioids or metabolites in serum
Month 2
Qualitive comparison of medication compliance between groups
Time Frame: Month 3
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)
Time Frame: Day 0
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
Time Frame: Month 1
Prescription Opioid Misuse Index (POMI)
Month 1
Compare observed medication misuse between groups
Time Frame: Month 2
Prescription Opioid Misuse Index (POMI)
Month 2
Compare observed medication misuse between groups
Time Frame: Month 3
Prescription Opioid Misuse Index (POMI)
Month 3
Correlation between predicted phenotype and observed metabolic ratios
Time Frame: Month 1
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
Time Frame: Month 2
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
Time Frame: Month 3
Products/substrate ratio measured by high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS)
Month 3
Metabolic profile of patients
Time Frame: Month 1
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
Time Frame: Month 2
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
Time Frame: Month 3
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
Time Frame: Month 1
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
Time Frame: Month 2
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
Time Frame: Month 3
Concentration of tramadol, codeine or oxycodone and their metabolites by Liquid chromatography-tandem mass spectrometry (LC-MS-MS)
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2018

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIMAO/2017-02/JCB-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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