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 |
| Protocol serial number | 7230 |
| Sponsor | Leeds Teaching Hospitals NHS Trust (UK) |
| Funder | Napp Pharmaceuticals (UK) |
- 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
Scientific
Seacroft Hospital
Pain Management Servces, L Ward
Leeds
LS14 6UH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre non-randomised interventional screening and treatment trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) | Proportion of chronic pain |
| Key secondary outcome measure(s) | Codeine non-responsiveness |
| Completion date | 15/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 150 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 15/09/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Seacroft Hospital
Leeds
LS14 6UH
United Kingdom
LS14 6UH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/08/2016: No publications found, verifying study status with principal investigator.
