A population study into the prevalence and genetic profile of patients with chronic pain who do not respond to oral codeine

ISRCTN ISRCTN16874724
DOI https://doi.org/10.1186/ISRCTN16874724
Secondary identifying numbers 7230
Submission date
12/05/2010
Registration date
12/05/2010
Last edited
02/08/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Helen Radford
Scientific

Seacroft Hospital
Pain Management Servces, L Ward
Leeds
LS14 6UH
United Kingdom

Study information

Study designSingle-centre non-randomised interventional screening and treatment trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA single site, pilot population study into the prevalence and genetic profile of patients with chronic pain who do not respond to oral codeine
Study objectivesThe goal of pain management is to provide symptom relief and improve an individual's level of functioning. Prescription of analgesics follows the World Health Organization (WHO) Pain Relief 3 step ladder. 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.
Ethics approval(s)MREC, 09/01/2009, ref: 08/H1307/132
Health condition(s) or problem(s) studiedTopic: Congenital Disorders; Subtopic: Congenital Disorders (all Subtopics); Disease: Clinical Genetics
InterventionA 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, oral fluid and urine samples for genetic testing and codeine levels.
Intervention typeOther
Primary outcome measureProportion of chronic pain
Secondary outcome measuresCodeine non-responsiveness
Overall study start date01/09/2009
Completion date15/09/2010

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsPlanned sample size: 150
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/2009
Date of final enrolment15/09/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Seacroft Hospital
Leeds
LS14 6UH
United Kingdom

Sponsor information

Leeds Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre

Research and Development
34 Hyde Terrace
Leeds
LS2 9LN
England
United Kingdom

Website http://www.leedsteachinghospitals.com/
ROR logo "ROR" https://ror.org/00v4dac24

Funders

Funder type

Industry

Napp Pharmaceuticals (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

02/08/2016: No publications found, verifying study status with principal investigator.