Pharmacogenomics of opioids: an investigation of the genetic determinants of variability in analgesic response to opioids

ISRCTN ISRCTN35444083
DOI https://doi.org/10.1186/ISRCTN35444083
Protocol serial number N0258123628
Sponsor Department of Health
Funder The Royal Marsden NHS Trust
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
19/10/2016
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

Dr Julia Riley
Scientific

Palliative Care
Royal Marsden NHS Trust
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom

Phone +44 (0)20 7352 8171
Email Julia.Riley@rmh.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titlePharmacogenomics of opioids: an investigation of the genetic determinants of variability in analgesic response to opioids
Study objectivesThe primary aim of this research project is to test the hypothesis that inter-subject variability in response to morphine is determined by polymorphisms in the u-opioid receptor gene.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAnalgesic response to opioids
InterventionRandomised, blinded (Phase 2).
Each subject will act as their own control. On visit one, subjects will be randomised to receive either intravenous morphine or intravenous saline (placebo). They will then cross-over to receive placebo or morphine respectively at the second visit.
Intervention typeOther
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/10/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration100
Key inclusion criteriaTotal number RMH patients 100
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/10/2003
Date of final enrolment01/10/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Palliative Care
London
SW3 6JJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

19/10/2016: No publications found in PubMed, verifying study status with principal investigator.