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

C

Centre Hospitalier Universitaire de Nīmes

Status

Withdrawn

Conditions

Non-cancerous Chronic Pain

Treatments

Other: Pharmacogenetic analysis allowing personalized opioid prescription
Other: Standard opioid prescription

Study type

Interventional

Funder types

Other

Identifiers

NCT03498014
NIMAO/2017-02/JCB-01

Details and patient eligibility

About

The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

Prescription as standard
Active Comparator group
Treatment:
Other: Standard opioid prescription
Pharmacogenetic-guided prescription
Experimental group
Treatment:
Other: Pharmacogenetic analysis allowing personalized opioid prescription

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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