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Trial registered on ANZCTR
Registration number
ACTRN12613000327785
Ethics application status
Approved
Date submitted
21/03/2013
Date registered
25/03/2013
Date last updated
9/04/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Impact of pharmacogenomics and metabolism on the effectiveness and toxicity of racemic ketamine in palliative care and chronic pain patients
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Scientific title
Evaluation of the clinical pharmacology and pharmacogenomics of ketamine in palliative care patients and chronic pain patients
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Secondary ID [1]
282160
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic pain patients
288668
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Condition category
Condition code
Anaesthesiology
289013
289013
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Ketamine 24 hour continuous intravenous infusions of 100 (day 1), 300 (day 2) and 500 mg (day 3) per day over a total of 3 days in palliative medicine and 5 days (500 mg/day on day 4 and 5) in chronic pain patients. Total intervention is a maximum of 5 days.
Blood samples collected to assess pharmacokinetics, metabolism to norketamine, CYP2B6 genetic polymorphisms.
Relationship between plasma concentrations and a) pain scores and b) adverse effects
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Intervention code [1]
286769
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Treatment: Drugs
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Comparator / control treatment
No control group as this is a pharmacokinetic/pharmacogenomic study
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Relationship of plasma ketamine and/or norketamine concentrations to efficacy of pain attenuation (pain scores 100 mm VAS) and adverse effects (NCI Criteria especially psychotomimetic)
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Assessment method [1]
289128
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Timepoint [1]
289128
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Day 3
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Secondary outcome [1]
301893
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Relationship of CYP2B6 polymorphism (*6 variant) to plasma ketamine and norketamine concentrations (LC-MS assay) using gene-dose test (Jonckheere-Terpstra) ;
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Assessment method [1]
301893
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Timepoint [1]
301893
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end of days 1, 2 and /or 3
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Eligibility
Key inclusion criteria
Able to be commenced on ketamine based on clinical grounds for refractory cancer or other pain.
Fluent in english language.
Able to participate in the monitoring of pain and adverse effects
Males and females over 18 years
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Minimum age
18
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with poor venous access
patients in whom significant hypertension or tachycardia would be potentially dangerous
Adverse reaction to ketamine in the past
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients for whom ketamine is indicated on clinical grounds
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
no randomisation as the study is investigating ketamine clinical pharmacology per se and the drug is being used on clinical grounds
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
29/08/2012
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Actual
17/10/2012
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Date of last participant enrolment
Anticipated
18/12/2013
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Actual
27/03/2014
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Date of last data collection
Anticipated
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Actual
20/05/2014
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Sample size
Target
50
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Accrual to date
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Final
49
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Funding & Sponsors
Funding source category [1]
286929
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Self funded/Unfunded
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Name [1]
286929
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Andrew Somogyi
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Address [1]
286929
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Discipline of Pharmacology
School of Medical Sciences
University of Adelaide
Frome Road
Adelaide 5005
South Australia
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Country [1]
286929
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Australia
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Primary sponsor type
Individual
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Name
Andrew Somogyi
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Address
Discipline of Pharmacology
School of Medical Sciences
University of Adelaide
Frome Road
Adelaide 5005
South Australia
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Country
Australia
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Secondary sponsor category [1]
285717
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Individual
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Name [1]
285717
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Associate Prof Kate Jackson
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Address [1]
285717
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Palliative Care
McCulloch House
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
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Country [1]
285717
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288985
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Southern Health HREC
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Ethics committee address [1]
288985
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246 Clayton Road
Clayton 3168
Victoria
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Ethics committee country [1]
288985
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Australia
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Date submitted for ethics approval [1]
288985
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Approval date [1]
288985
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24/07/2012
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Ethics approval number [1]
288985
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12159L
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Summary
Brief summary
The primary purpose is to determine whether the effectiveness of ketamine and its toxicity are related to the circulating plasma concentrations of ketamine and/or its active metabolite norketamine.
The study hypothesis is that there is a plasma concentration window for ketamine, below which it is ineffective to control pain and above which it produces adverse effects, and that the concentration is dependent on the patient's genotype for CYP2B6
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Trial website
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Trial related presentations / publications
Li Y, Jackson KA, Slon B, Hardy JR, Franco M, William L, Poon P, Coller JK, Hutchinson MR, Currow DC, Somogyi AA.
CYP2B6*6 allele and age substantially reduce steady-state ketamine clearance in chronic pain patients: impact on adverse effects.
British Journal of Clinical Pharmacology. 2015;80(2):276-284.
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Public notes
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Attachments [1]
2575
2575
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/AnzctrAttachments/363899-Ketamine BJCP Steven Li.pdf
(Publication)
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Attachments [2]
2576
2576
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/AnzctrAttachments/363899(v09-04-2018-13-32-40)-Ketamine BJCP Steven Li.pdf
(Publication)
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Contacts
Principal investigator
Name
38654
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A/Prof Kate Jackson
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Address
38654
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Supportive and Palliative Care Unit
McCulloch House
Monash Medical Centre
246 Clayton Road
Clayton, 3168
Victoria
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Country
38654
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Australia
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Phone
38654
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+61 03 9594 5347
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Fax
38654
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Email
38654
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[email protected]
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Contact person for public queries
Name
38655
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A/Prof Kate Jackson
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Address
38655
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Supportive and Palliative Care Unit
McCulloch House
Monash Medical Centre
246 Clayton Road
Clayton, 3168
Victoria
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Country
38655
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Australia
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Phone
38655
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+61 03 9594 5347
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Fax
38655
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Email
38655
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[email protected]
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Contact person for scientific queries
Name
38656
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Prof Andrew Somogyi
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Address
38656
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Discipline of Pharmacology
Faculty of Health Sciences
University of Adelaide
Adelaide 5005
South Australia
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Country
38656
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Australia
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Phone
38656
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+ 61 8 83135572
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Fax
38656
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Email
38656
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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