Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
7230
Study information
Scientific title
A single site, pilot population study into the prevalence and genetic profile of patients with chronic pain who do not respond to oral codeine
Acronym
Study hypothesis
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 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
Study design
Single-centre non-randomised interventional screening and treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Congenital Disorders; Subtopic: Congenital Disorders (all Subtopics); Disease: Clinical Genetics
Intervention
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, oral fluid and urine samples for genetic testing and codeine levels.
Intervention type
Other
Primary outcome measure
Proportion of chronic pain
Secondary outcome measures
Codeine non-responsiveness
Overall study start date
01/09/2009
Overall study end date
15/09/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
Planned sample size: 150
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2009
Recruitment end date
15/09/2010
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Seacroft Hospital
Leeds
LS14 6UH
United Kingdom
Sponsor information
Organisation
Leeds Teaching Hospitals NHS Trust (UK)
Sponsor details
Research and Development
34 Hyde Terrace
Leeds
LS2 9LN
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
http://www.leedsteachinghospitals.com/
ROR
Funders
Funder type
Industry
Funder name
Napp Pharmaceuticals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |