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.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000366651

Enrollment

Registered

2005-09-13

Start date

2006-06-01

Completion date

2012-12-26

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Oral morphine or oxycodone.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results