Condition category
Signs and Symptoms
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
02/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Helen Radford

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Phase IV

Drug names

Primary outcome measures

Proportion of chronic pain

Secondary outcome measures

Codeine non-responsiveness

Overall trial start date

01/09/2009

Overall trial end date

15/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.leedsteachinghospitals.com/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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