A Population Study in Patients Who Do Not Respond to Oral Codeine

• Research type

  Research Study

• Full title

  A POPULATION STUDY INTO THE PREVALENCE AND GENETIC PROFILE OF PATIENTS WITH CHRONIC PAIN WHO DO NOT RESPOND TO ORAL CODEINE: A single site, pilot population study into the prevalence and genetic profile of patients with chronic pain who do not respond to oral codeine.

• IRAS ID

  409

• Sponsor organisation

  The Leeds Teaching Hospitals NHS Trust

• Eudract number

  2007-006184-70

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The goal of pain management is to provide symptom relief and improve an individual??s level of functioning. Prescription of analgesics follows the World Health Organisation Pain Relief 3 step ladder (1986). Step one is a non-opioid medication (e.g. paracetamol), step two is a weak opioid (e.g. Codeine phosphate) and step three is an opioid. It is estimated that 5 -10% of Caucasians metabolise codeine poorly as a result of non-functioning alleles of the CYP2D6 gene; a further 10-15% are termed intermediate metabolisers. Potentially, therefore, up to 25% of a Caucasian population will lack an optimal analgesic response to codeine. The ability to predict clinical efficacy and identify these variations through an easily executed, repeatable, cost effective clinical test would be a valuable tool both to clinicians and patients. The benefits may include enhanced patient compliance due to better clinical response, improved patient safety, and reduced costs.This is a single site population study to determine the proportion of chronic pain patients who lack an analgesic response to codeine (i.e. codeine non-responders) and to investigate whether the proportion of codeine non-responders in the chronic pain population is greater than the well known figure of 10% seen in the general population. It has been funded by an educational grant from Napp Pharmaceuticals Ltd.A sample of 150 patients will be enrolled from the Leeds Chronic Pain Clinic over 18 months. Participants will attend the pain research clinic at Seacroft Hospital Leeds on three separate occasions (screening, treatment visit, end of study visit). Their participation will be no longer than 15 days from screening to follow up. Each participant will be given 5 days of oral codeine, complete pain questionnaires and provide saliva, oraflud and urine samples for genetic testing and codeine metabolites to enable genotyping.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  08/H1307/132

• Date of REC Opinion

  9 Jan 2009

• REC opinion

  Further Information Favourable Opinion