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

NCT03498014 | Withdrawn

• 1 other identifier: NIMAO/2017-02/JCB-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-cancerous Chronic Pain

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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)

  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)

  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)

  Month 3

Secondary Outcomes (42)

• Number of undesirable events associated to opioid between groups

  Month 1

• Number of undesirable events associated to opioid between groups

  Month 2

• Number of undesirable events associated to opioid between groups

  Month 3

• Number of undesirable events associated to opioid between groups

  Month 1

• Number of undesirable events associated to opioid between groups

  Month 2

Study Arms (2)

Prescription as standard

ACTIVE COMPARATOR

Other: Standard opioid prescription

Pharmacogenetic-guided prescription

EXPERIMENTAL

Other: Pharmacogenetic analysis allowing personalized opioid prescription

Interventions

Pharmacogenetic analysis allowing personalized opioid prescription OTHER

Genotypic of patient to determine optimal opioid treatment (tramadol, codeine or oxycodone)

Pharmacogenetic-guided prescription

Standard opioid prescription OTHER

Opioid prescription made without reference to patient genetic profile (tramadol, codeine or oxycodone)

Prescription as standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Study Officials

• Jean-Christophe Boyer

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 13, 2018
• Study Start: July 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

FR (1)