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

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ClinicalTrials.gov Identifier: NCT03498014
Recruitment Status : Not yet recruiting
First Posted : April 13, 2018
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment Phase
Non-cancerous Chronic Pain Other: Pharmacogenetic analysis allowing personalized opioid prescription Other: Standard opioid prescription Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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)

  7. Compare clinical therapeutic efficacy between groups [ Time Frame: Month 1 ]
    Patient Global Impression of Change (PGIC) score; value between 1-7

  8. Compare clinical therapeutic efficacy between groups [ Time Frame: Month 2 ]
    Patient Global Impression of Change (PGIC) score; value between 1-7

  9. Compare clinical therapeutic efficacy between groups [ Time Frame: Month 3 ]
    Patient Global Impression of Change (PGIC) score; value between 1-7

  10. Compare patient-reported pain between groups [ Time Frame: Day 0 ]
    Visual analog scare 1-10

  11. Compare patient-reported pain between groups [ Time Frame: Week 2 ]
    Visual analog scare 1-10

  12. Compare patient-reported pain between groups [ Time Frame: Month 1 ]
    Visual analog scare 1-10

  13. Compare patient-reported pain between groups [ Time Frame: Month 2 ]
    Visual analog scare 1-10

  14. Compare patient-reported pain between groups [ Time Frame: Month 3 ]
    Visual analog scare 1-10

  15. Compare neuropathic pain between groups [ Time Frame: Day 0 ]
    DN4 score (Douleur Neuropathique 4 Questions); score between 0-10

  16. Compare neuropathic pain between groups [ Time Frame: Month 1 ]
    DN4 score (Douleur Neuropathique 4 Questions); score between 0-10

  17. Compare neuropathic pain between groups [ Time Frame: Month 2 ]
    DN4 score (Douleur Neuropathique 4 Questions); score between 0-10

  18. Compare neuropathic pain between groups [ Time Frame: Month 3 ]
    DN4 score (Douleur Neuropathique 4 Questions); score between 0-10

  19. Compare benefit/risk ratio of treatment between groups [ Time Frame: Month 1 ]
    Overall Benefit of Analgesics Score (OBAS); score between 0-32

  20. Compare benefit/risk ratio of treatment between groups [ Time Frame: Month 2 ]
    Overall Benefit of Analgesics Score (OBAS); score between 0-32

  21. Compare benefit/risk ratio of treatment between groups [ Time Frame: Month 3 ]
    Overall Benefit of Analgesics Score (OBAS); score between 0-32

  22. 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

  23. 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

  24. 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)

  25. 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)

  26. 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)

  27. Qualitive comparison of medication compliance between groups [ Time Frame: Month 1 ]
    Presence/absence of opioids or metabolites in serum

  28. Qualitive comparison of medication compliance between groups [ Time Frame: Month 2 ]
    Presence/absence of opioids or metabolites in serum

  29. Qualitive comparison of medication compliance between groups [ Time Frame: Month 3 ]
    Presence/absence of opioids or metabolites in serum

  30. 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)

  31. Compare observed medication misuse between groups [ Time Frame: Month 1 ]
    Prescription Opioid Misuse Index (POMI)

  32. Compare observed medication misuse between groups [ Time Frame: Month 2 ]
    Prescription Opioid Misuse Index (POMI)

  33. Compare observed medication misuse between groups [ Time Frame: Month 3 ]
    Prescription Opioid Misuse Index (POMI)

  34. 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)

  35. 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)

  36. 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)

  37. 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

  38. 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

  39. 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

  40. 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)

  41. 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)

  42. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498014


Contacts
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Contact: Jean-Christophe Boyer, MD 06 83 18 85 13 jean.christophe.boyer@chu-nimes.fr

Locations
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France
CHU Nimes Not yet recruiting
Nîmes, France, 30029
Contact: Anissa Megzari       drc@chu-nimes.fr   
Principal Investigator: Jean-Christophe Boyer, MD         
Principal Investigator: Olivier Bredeau, MD         
Principal Investigator: Eric Viel, MD         
Sub-Investigator: Nathalie Maignaut-Licata, MD         
Sub-Investigator: Sophie Bregier, MD         
Sub-Investigator: Alexandre Evrard, MD         
Sub-Investigator: Serge Lumbroso, MD         
Sub-Investigator: Jean-Marie Kinowski, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Jean-Christophe Boyer CHU Nimes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03498014     History of Changes
Other Study ID Numbers: NIMAO/2017-02/JCB-01
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents