Trial Review

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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
Scientific title
Evaluation of the clinical pharmacology and pharmacogenomics of ketamine in palliative care patients and chronic pain patients
Secondary ID [1] 282160 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain patients 288668 0
Condition category
Condition code
Anaesthesiology 289013 289013 0 0
Pain management

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 286769 0
Treatment: Drugs
Comparator / control treatment
No control group as this is a pharmacokinetic/pharmacogenomic study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289128 0
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)
Timepoint [1] 289128 0
Day 3
Secondary outcome [1] 301893 0
Relationship of CYP2B6 polymorphism (*6 variant) to plasma ketamine and norketamine concentrations (LC-MS assay) using gene-dose test (Jonckheere-Terpstra) ;
Timepoint [1] 301893 0
end of days 1, 2 and /or 3

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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients for whom ketamine is indicated on clinical grounds
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/08/2012
Actual
17/10/2012
Date of last participant enrolment
Anticipated
18/12/2013
Actual
27/03/2014
Date of last data collection
Anticipated
Actual
20/05/2014
Sample size
Target
50
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA

Funding & Sponsors
Funding source category [1] 286929 0
Self funded/Unfunded
Name [1] 286929 0
Andrew Somogyi
Country [1] 286929 0
Australia
Primary sponsor type
Individual
Name
Andrew Somogyi
Address
Discipline of Pharmacology
School of Medical Sciences
University of Adelaide
Frome Road
Adelaide 5005
South Australia
Country
Australia
Secondary sponsor category [1] 285717 0
Individual
Name [1] 285717 0
Associate Prof Kate Jackson
Address [1] 285717 0
Palliative Care
McCulloch House
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country [1] 285717 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288985 0
Southern Health HREC
Ethics committee address [1] 288985 0
246 Clayton Road
Clayton 3168
Victoria
Ethics committee country [1] 288985 0
Australia
Date submitted for ethics approval [1] 288985 0
Approval date [1] 288985 0
24/07/2012
Ethics approval number [1] 288985 0
12159L

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
Trial website
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.
Public notes
Attachments [1] 2575 2575 0 0
/AnzctrAttachments/363899-Ketamine BJCP Steven Li.pdf (Publication)
Attachments [2] 2576 2576 0 0
/AnzctrAttachments/363899(v09-04-2018-13-32-40)-Ketamine BJCP Steven Li.pdf (Publication)

Contacts
Principal investigator
Name 38654 0
A/Prof Kate Jackson
Address 38654 0
Supportive and Palliative Care Unit
McCulloch House
Monash Medical Centre
246 Clayton Road
Clayton, 3168
Victoria
Country 38654 0
Australia
Phone 38654 0
+61 03 9594 5347
Fax 38654 0
Email 38654 0
kate.jackson@southernhealth.org.au
Contact person for public queries
Name 38655 0
A/Prof Kate Jackson
Address 38655 0
Supportive and Palliative Care Unit
McCulloch House
Monash Medical Centre
246 Clayton Road
Clayton, 3168
Victoria
Country 38655 0
Australia
Phone 38655 0
+61 03 9594 5347
Fax 38655 0
Email 38655 0
kate.jackson@southernhealth.org.au
Contact person for scientific queries
Name 38656 0
Prof Andrew Somogyi
Address 38656 0
Discipline of Pharmacology
Faculty of Health Sciences
University of Adelaide
Adelaide 5005
South Australia
Country 38656 0
Australia
Phone 38656 0
+ 61 8 83135572
Fax 38656 0
Email 38656 0
andrew.somogyi@adelaide.edu.au

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.