ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breakthrough Pain

Condition category

Condition code

Alternative and Complementary Medicine

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Oral morphine or oxycodone.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Not Applicable

Control group

Active

Outcomes

Primary outcome [1]

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]

At 30 minutes between the three doses.

Secondary outcome [1]

1. To determine lowest effective dose of either oral immediate release morphine or oxycodone solution for breakthrough pain.

Timepoint [1]

30,60 and 120 minutes after study dose

Secondary outcome [2]

2. To determine difference in the side effect profile between doses of study doses.

Timepoint [2]

30,60 and 120 minutes after study dose

Secondary outcome [3]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/05/2006

Actual

1/06/2006

Date of last participant enrolment

Anticipated

30/06/2015

Actual

26/12/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

138

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [2]

Mater Adult Hospital - South Brisbane

Recruitment postcode(s) [1]

5001 - Adelaide

Recruitment postcode(s) [2]

4101 - South Brisbane

Recruitment outside Australia

Country [1]

Singapore

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Repatriation General Hospital

Address

Daws Road
Daw Park 5041

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Flinders Drive 
Bedford Park
SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/06/2005

Approval date [1]

16/01/2006

Ethics approval number [1]

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

Prof David Currow

Address

Palliative and Supportive Services Flinders University Bedford Park SA 5042

Country

Australia

Phone

+61 08 82751057

Fax

+61 08 8275 1201

david.currow@health.sa.gov.au

Contact person for public queries

Name

David Currow

Address

Palliative and Supportive Services
Flinders University
Bedford Park SA 5042

Country

Australia

Phone

+61 08 82751057

Fax

+61 08 8275 1201

david.currow@health.sa.gov.au

Contact person for scientific queries

Name

David Currow

Address

Palliative and Supportive Services Flinders University Bedford Park SA 5042

Country

Australia

Phone

+61 08 82751057

Fax

+61 08 8275 1201

daivd.currow@health.sa.gov.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

Source	Title	Year of Publication	DOI
Embase	A randomized, double-blind, crossover, dose ranging study to determine the optimal dose of oral opioid to treat breakthrough pain for patients with advanced cancer already established on regular opioids.	2020	https://dx.doi.org/10.1002/ejp.1548

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically