Trial registered on ANZCTR


Trial ID
ACTRN12605000366651
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
13/09/2005
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind, dose-ranging study to determine the optimal dose of oral morphine or oxycodone needed to treat breakthrough pain for people on regular opioid in the palliative care setting.
Scientific title
A double-blind, dose-ranging study to determine the optimal dose of oral morphine or oxycodone needed to treat breakthrough pain for people on regular opioid in the palliative care setting
Secondary ID [1] 288165 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breakthrough Pain 461 0
Condition category
Condition code
Alternative and complementary medicine 538 538 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral morphine or oxycodone.
Intervention code [1] 163 0
Treatment: drugs
Comparator / control treatment
Not Applicable
Control group
Active

Outcomes
Primary outcome [1] 629 0
To determine the optimal dose of either oral immediate release morphine or oxycodone solution for breakthrough pain based on the % reduction in pain scores at 30 minutes between the three doses.
Timepoint [1] 629 0
At 30 minutes between the three doses.
Secondary outcome [1] 1297 0
1. To determine lowest effective dose of either oral immediate release morphine or oxycodone solution for breakthrough pain.
Timepoint [1] 1297 0
30,60 and 120 minutes after study dose
Secondary outcome [2] 1298 0
2. To determine difference in the side effect profile between doses of study doses.
Timepoint [2] 1298 0
30,60 and 120 minutes after study dose
Secondary outcome [3] 1299 0
A subset of 15 patients using Morphine as their regular breakthrough medication will be asked to provide blood samples for the purposes of an exploratory pharmacokinetic study .
Timepoint [3] 1299 0
Not Applicable

Eligibility
Key inclusion criteria
English speaking, AKPS performance status of 100 to 30, Calculated creatinine clearance of > 20 ml/minVenous blood sample for creatinine level, Stable background oral opioid for the previous 4 days, Successfully using breakthrough doses, Physically able to complete study measures.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Confusion, Uncontrolled nausea or vomiting, Suspected gastro-intestinal obstruction, Known or suspected hypersensitivity to morphine or oxycodone, Past history of substance misuse, Declines to participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Doses are prepared in central pharmacy and dispensed in separate numbered containers. The allocation is externally prepared and concealed from the investigators by placing each allocation in sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Computer generated; blocking used.
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 4968 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 4969 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 12460 0
5001 - Adelaide
Recruitment postcode(s) [2] 12461 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 7424 0
Singapore
State/province [1] 7424 0

Funding & Sponsors
Funding source category [1] 596 0
Self funded/Unfunded
Name [1] 596 0
Address [1] 596 0
Country [1] 596 0
Primary sponsor type
Hospital
Name
Repatriation General Hospital
Address
Daws Road
Daw Park 5041
Country
Australia
Secondary sponsor category [1] 485 0
None
Name [1] 485 0
Nil
Address [1] 485 0
Country [1] 485 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1693 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 1693 0
Flinders Drive
Bedford Park
SA 5042
Ethics committee country [1] 1693 0
Australia
Date submitted for ethics approval [1] 1693 0
20/06/2005
Approval date [1] 1693 0
16/01/2006
Ethics approval number [1] 1693 0
66/067

Summary
Brief summary
Sometimes patients who have strong pain and take regular morphine or oxycodone (opioid drugs) to treat their pain, experience times when pain breaks through the normal control provided by regular doses of pain medication. This is called breakthrough pain.
Usually, extra doses of morphine or oxycodone, called breakthrough doses, are prescribed to treat this pain. The dose of breakthrough medication that will have the best chance of relieving your pain, together with the least chance of causing unwanted side effects, is not known with certainty.
Presently doctors determines the dose, by calculating each dose as a percent of the daily dose of regular pain medication. The calculated percent varies between doctors, we do not know if any calculated percent is better or worse than another percent.
The purpose of this research study is to determine if there is a breakthrough dose calculation better for breakthrough pain and with fewer side effects.

Who can participate in this study?

Anyone over 18 years of age taking regular opioid medication for pain and who has taken at least one breakthrough dose in the last 7 days.

You will then be provided with six doses of oral morphine or oxycodone solution (depending on your usual medication) to use when you have breakthrough pain over the 28 day study period.You will take a total of 3 different strengths of medication over the 6 doses. You can be assured that you will take a dose of medication that would normally be expected to give relief each time.
Each dose will be individually packed and is a complete dose in itself. Each time you need a breakthrough dose for pain, for the first occurrence of pain for the day you will be asked to take one of the doses supplied by the study.
After each study dose taken, you will need to answer some questions about your pain and other symptoms four times in the records packed with the doses.
You will be in the study until all 6 study doses have been taken, for up to 28 days. During that time you will be contacted by telephone by the study nurse each week.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36222 0
Prof David Currow
Address 36222 0
Palliative and Supportive Services Flinders University Bedford Park SA 5042
Country 36222 0
Australia
Phone 36222 0
+61 08 82751057
Fax 36222 0
+61 08 8275 1201
Email 36222 0
david.currow@health.sa.gov.au
Contact person for public queries
Name 9352 0
Prof David Currow
Address 9352 0
Palliative and Supportive Services
Flinders University
Bedford Park SA 5042
Country 9352 0
Australia
Phone 9352 0
+61 08 82751057
Fax 9352 0
+61 08 8275 1201
Email 9352 0
david.currow@health.sa.gov.au
Contact person for scientific queries
Name 280 0
Prof David Currow
Address 280 0
Palliative and Supportive Services Flinders University Bedford Park SA 5042
Country 280 0
Australia
Phone 280 0
+61 08 82751057
Fax 280 0
+61 08 8275 1201
Email 280 0
daivd.currow@health.sa.gov.au