Non-cancerous Chronic PainAlgoPGxNCT03498014
Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.
A study testing Pharmacogenetic analysis allowing personalized opioid prescription and Standard opioid prescription in people with Non-cancerous Chronic Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-cancerous Chronic Pain
- What is being tested?
- Pharmacogenetic analysis allowing personalized opioid prescription and Standard opioid prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance.
- Conditions
- Non-cancerous Chronic Pain
- Being tested
- Pharmacogenetic analysis allowing personalized opioid prescription, Standard opioid prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic analysis allowing personalized opioid prescriptionOther
Genotypic of patient to determine optimal opioid treatment (tramadol, codeine or oxycodone)
Standard opioid prescriptionOther
Opioid prescription made without reference to patient genetic profile (tramadol, codeine or oxycodone)
| Study group | Role | What they receive |
|---|---|---|
| Prescription as standard | Active comparator | Not described Receives: Other: Standard opioid prescription |
| Pharmacogenetic-guided prescription | Experimental | Not described Receives: Other: Pharmacogenetic analysis allowing personalized opioid prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Month 3
Secondary outcomes (42)
Number of undesirable events associated to opioid between groups
Total number of undesirable event of at least grade 3 according to list in protocol
Measured: Month 1
Number of undesirable events associated to opioid between groups
Total number of undesirable event of at least grade 3 according to list in protocol
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Month 3
Compare clinical therapeutic efficacy between groups
Patient Global Impression of Change (PGIC) score; value between 1-7
Measured: Month 1
Compare clinical therapeutic efficacy between groups
Patient Global Impression of Change (PGIC) score; value between 1-7
Measured: Month 2
Compare clinical therapeutic efficacy between groups
Patient Global Impression of Change (PGIC) score; value between 1-7
Measured: Month 3
Compare patient-reported pain between groups
Visual analog scare 1-10
Measured: Day 0
Compare patient-reported pain between groups
Visual analog scare 1-10
Measured: Week 2
Compare patient-reported pain between groups
Visual analog scare 1-10
Measured: Month 1
Compare patient-reported pain between groups
Visual analog scare 1-10
Measured: Month 2
Compare patient-reported pain between groups
Visual analog scare 1-10
Measured: Month 3
Compare neuropathic pain between groups
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Measured: Day 0
Compare neuropathic pain between groups
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Measured: Month 1
Compare neuropathic pain between groups
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Measured: Month 2
Compare neuropathic pain between groups
DN4 score (Douleur Neuropathique 4 Questions); score between 0-10
Measured: Month 3
Compare benefit/risk ratio of treatment between groups
Overall Benefit of Analgesics Score (OBAS); score between 0-32
Measured: Month 1
Compare benefit/risk ratio of treatment between groups
Overall Benefit of Analgesics Score (OBAS); score between 0-32
Measured: Month 2
Compare benefit/risk ratio of treatment between groups
Overall Benefit of Analgesics Score (OBAS); score between 0-32
Measured: Month 3
Compare quality of life between patients in each group
Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100
Measured: Day 0
Compare quality of life between patients in each group
Quality of life Short Form 12 (SF-12) questionnaire; score between 0-100
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Month 3
Qualitive comparison of medication compliance between groups
Presence/absence of opioids or metabolites in serum
Measured: Month 1
Qualitive comparison of medication compliance between groups
Presence/absence of opioids or metabolites in serum
Measured: Month 2
Qualitive comparison of medication compliance between groups
Presence/absence of opioids or metabolites in serum
Measured: 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)
Measured: Day 0
Compare observed medication misuse between groups
Prescription Opioid Misuse Index (POMI)
Measured: Month 1
Compare observed medication misuse between groups
Prescription Opioid Misuse Index (POMI)
Measured: Month 2
Compare observed medication misuse between groups
Prescription Opioid Misuse Index (POMI)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study startJul 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: no started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cancerous Chronic PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe Boyer, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498014
- Sponsor's protocol ID
- NIMAO/2017-02/JCB-01
- Acronym
- AlgoPGx
- Status last verified
- Feb 2023
- First submitted
- 29 Mar 2018
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.
- ClinicalTrials.gov ID
- NCT03498014
- Acronym / sponsor ID
- AlgoPGx / NIMAO/2017-02/JCB-01
- Conditions
- Non-cancerous Chronic Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prescription as standard | Active comparator | Other: Standard opioid prescription |
| Pharmacogenetic-guided prescription | Experimental | Other: Pharmacogenetic analysis allowing personalized opioid prescription |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenetic analysis allowing personalized opioid prescriptionGenotypic of patient to determine optimal opioid treatment (tramadol, codeine or oxycodone) | Other | Pharmacogenetic-guided prescription |
| Standard opioid prescriptionOpioid prescription made without reference to patient genetic profile (tramadol, codeine or oxycodone) | Other | Prescription as standard |
Primary outcome
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
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
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 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)
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)
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)
42 secondary outcomes
Number of undesirable events associated to opioid between groups
Time frame: Month 1
Number of undesirable events associated to opioid between groups
Time frame: Month 2
Number of undesirable events associated to opioid between groups
Time frame: Month 3
Number of undesirable events associated to opioid between groups
Time frame: Month 1
Number of undesirable events associated to opioid between groups
Time frame: Month 2
Number of undesirable events associated to opioid between groups
Time frame: Month 3
Compare clinical therapeutic efficacy between groups
Time frame: Month 1
Compare clinical therapeutic efficacy between groups
Time frame: Month 2
Compare clinical therapeutic efficacy between groups
Time frame: Month 3
Compare patient-reported pain between groups
Time frame: Day 0
Compare patient-reported pain between groups
Time frame: Week 2
Compare patient-reported pain between groups
Time frame: Month 1
Compare patient-reported pain between groups
Time frame: Month 2
Compare patient-reported pain between groups
Time frame: Month 3
Compare neuropathic pain between groups
Time frame: Day 0
Compare neuropathic pain between groups
Time frame: Month 1
Compare neuropathic pain between groups
Time frame: Month 2
Compare neuropathic pain between groups
Time frame: Month 3
Compare benefit/risk ratio of treatment between groups
Time frame: Month 1
Compare benefit/risk ratio of treatment between groups
Time frame: Month 2
Compare benefit/risk ratio of treatment between groups
Time frame: Month 3
Compare quality of life between patients in each group
Time frame: Day 0
Compare quality of life between patients in each group
Time frame: Month 3
Compare medication compliance between groups
Time frame: Month 1
Compare medication compliance between groups
Time frame: Month 2
Compare medication compliance between groups
Time frame: Month 3
Qualitive comparison of medication compliance between groups
Time frame: Month 1
Qualitive comparison of medication compliance between groups
Time frame: Month 2
Qualitive comparison of 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)
Time frame: Day 0
Compare observed medication misuse between groups
Time frame: Month 1
Compare observed medication misuse between groups
Time frame: Month 2
Compare observed medication misuse between groups
Time frame: Month 3
Correlation between predicted phenotype and observed metabolic ratios
Time frame: Month 1
Correlation between predicted phenotype and observed metabolic ratios
Time frame: Month 2
Correlation between predicted phenotype and observed metabolic ratios
Time frame: Month 3
Metabolic profile of patients
Time frame: Month 1
Metabolic profile of patients
Time frame: Month 2
Metabolic profile of patients
Time frame: Month 3
Correlation between saliva and plasma concentration of opioids
Time frame: Month 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Christophe Boyer principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenetic analysis allowing personalized opioid prescription and Standard opioid prescription in people with Non-cancerous Chronic Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare presence/absence undesirable events associated to opioid between groups from predefined list (time frame: Month 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.