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ISRCTN
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ISRCTN65155201
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ClinicalTrials.gov identifier
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Public title
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A Prospective Randomized Controlled Trial of Morphine versus Oxycodone for
Cancer Pain: Genetic Determinants of Response to Opioids
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0258161811
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Study hypothesis
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1. To compare the response rates of morphine and oxycodone when used as first line strong opioids in moderate to severe cancer pain.
2.1 To compare the toxicity profiles of morphine and oxycodone and identify which factors
predict that need to switch from one opioid to the other.
2.2 To compare clinical, laboratory, genomic, proteomic and metabonomic parameters of the study populations in order to design a model that predicts response and non-response to morphine and oxycodone.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Moderate to severe cancer pain
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Participants - inclusion criteria
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1. Patients must have a clinical or histological diagnosis of cancer
2. Patients whose pain is not controlled on Step 2 analgesics (as defined by the World Health Organisation [WHO] analgesic ladder) who clinically require a strong opioid
3. Patients must be over 18 years of age
4. Patients must be able to give written informed consent
5. Patients must be willing to undergo genetic screening
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Participants - exclusion criteria
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1. Patients with renal failure (1.5 x upper limit of normal [ULN]). These patients should be treated with alfentanil as per palliative care guidelines.
2. Patients must not have been taking regular Step 3 analgesics in the last month
3. Patients requiring parenteral administration of opioids
4. Patients with predominantly neuropathic pain
5. Patients with predominantly incident pain
6. Patients with a clearly defined history of intolerance to morphine or oxycodone
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Anticipated start date
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01/05/2005
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Anticipated end date
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01/11/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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200
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Interventions
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Randomisation to receive oral morphine or oral oxycodone as first line Step 3 analgesics in moderate to severe cancer pain, and switch to alternative arm of study if lack of response to drug of initial study treatment arm.
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Primary outcome measure(s)
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Difference in response rate to morphine versus oxycodone.
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Secondary outcome measure(s)
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Differences in levels of toxicity and differences in pre-specified clinical, laboratory, genetic, immunological and proteomic determinants between the two study groups.
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Sources of funding
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The Palliative Care Research Fund
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Trial website
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Publications
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Contact name
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Dr
Julia
Riley
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Address
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The Royal Marsden Hospital
Fulham Road
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City/town
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London
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Zip/Postcode
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SW3 6JJ
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Country
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United Kingdom
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Sponsor
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The Royal Marsden NHS Foundation Trust (UK)
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Address
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Fulham Road
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City/town
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London
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Zip/Postcode
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SW3 6JJ
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Country
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United Kingdom
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Date applied
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18/03/2005
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Last edited
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03/12/2007
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Date ISRCTN assigned
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29/03/2005
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