This research study aims to see how well the study treatment, a drug-device combination performs as a possible treatment for diabetic peripheral neuropathic pain.
About this study
We are inviting adults to take part in this research trial aiming to reduce pain intensity for people with diabetic peripheral neuropathic pain.
The primary objective of the study is to evaluate the effectiveness of the study treatment via aerosol compared to placebo via the Syqe Fixed-dose Inhaler.
During the trial, participants will receive either study medicine or a placebo to be inhaled every day for up to 16 weeks.
Anticipated enrolment close date: 29 July 2025
Who can take part
You may be eligible to participate in this research project if you:
- Are 18 to 75 years of age
- Have Body Mass Index (BMI) between 18-40 kg/m2
- Are currently on a standard treatment for diabetic painful peripheral neuropathy that includes gabapentin or duloxetine or pregabalin
- Diagnosed with Type 1 or Type 2 Diabetes and with diabetic peripheral neuropathy
- Agree not to drive or operate heavy machinery during the study treatment period (free public transport will be provided)
You may be ineligible to participate in this research project if you:
- Have pain not due to the diabetic peripheral neuropathy
- Have any history of asthma, mental illness, major cardiovascular, kidney or liver disease, epilepsy
- Had any vaccines in last 6 weeks
What's involved
The study medicine or a placebo to be inhaled every day for up to 16 weeks.
The visits will involve collection of blood and urine, as well as medical assessment by the study team.
Other tests will include ECG, blood pressure, weight, lung function test, and questionnaires.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.