Testing new treatments, drugs and devices

IHMRI’s well-equipped Clinical Research and Trials Unit (CRTU) offers facilities and services for a range of clinical research studies and commercial clinical trials. Our region’s stable and accessible population base, which is set to grow to over 465,172 by 2036 (Wollongong City, Shellharbour City and Shoalhaven City Councils), demographic and economic diversity, and incidence of chronic disease, makes it ideal for population health studies and clinical trials. Read more about our region. To see the range of equipment and services available visit Assistance with clinical trials. Members of the community who are interested in taking part in clinical trials can read more at Participate in clinical trials.

Current clinical trials

There are a number of both commercial and investigator initiated clinical trials that are conducted within our clinical trials unit.  The CRTU supports a number of researchers from the University of Wollongong to conduct studies into a range of health concerns including dementia, diabetes, cardiovascular disease and mental illness. IHMRI is also home to the Australian Centre for Electromagnetic Bioeffects Research, led by Senior Professor Rodney Croft, which conducts a range of clinical trials, both in the dedicated sleep study rooms and in the faraday cage.    

A study investigating a potential treatment which may help improve brain structure and function, psychological wellbeing and quality of life in people living with early-stage dementia – now recruiting If you:

  • Aged between 55 and 75 and have a diagnosis of early-stage dementia 
  • Individuals who live at home, who have someone to support them throughout the duration of the study (e.g. family member, caregiver)
  • Eligible and willing participants will be required to take a capsule of either the trial drug or a placebo each morning and evening for 12 weeks

Then you may be eligible for this study.  If you are interested in finding out more, then please click on the now recruiting link to register your interest Download flyer

Enhance is conducting a research study to evaluate the impact of a nurse practitioner-led memory clinic for people living with dementia and their carer/ families.

The research will be conducted over a 12-month period and participants will be asked to complete a clinical interview every 3-months. These clinical interviews will go for about 90 minutes. The clinical interviews will include questions about cognition, daily function, quality of life, mental wellbeing.

The outcomes of this research will be used to improve services and resources for people living with dementia and their carer/ families. The findings will be presented in journals and at conferences so healthcare professionals can learn from this project.

Please register your interest in taking part via email or phone:

Amy Montgomery

Nurse Practitioner/ Lecturer

E: enhance@ihmri.org.au

T: 0456 845 196

The purpose of this study is to identify if a high intake of anthocyanins through either diet/dietary advice or supplementation for 6 months can sustainably delay or prevent memory loss progression in people at high risk for dementia – now recruiting If you:

  • We are inviting all adults aged 65 years and over with observed memory complaints to apply to participate in the research study
  • Participants will only be recruited to the study after being assessed by a researcher via a telephone interview 

Then you may be eligible for this study.  If you are interested in finding out more, then please click on the now recruiting link to register your interest Download flyer

This study will be investigating whether a treatment called Tozorakimab could help manage COPD exacerbations (often called flare-ups, where COPD symptoms get worse) in patients who are currently receiving treatment for COPD. If successful, the findings from this will help in the development of future treatments for individuals with COPD  – now recruiting If you:

  • Individuals aged 40 and above who have been diagnosed with COPD for at least one year
  • Must be a previous or current smoker
  • Must have had at least 1 COPD flare-up in the last 12 months
  • Must be regularly taking inhaled medication for COPD
  • Must not have any other clinically important pulmonary disease other than COPD
  • Must not have a current diagnosis of asthma
  • Must not have a planned major surgical procedure within the next 16 months
  • Must not have had a cancer diagnosis within the last 5 years (some skin cancers and cervical cancers can be included if treated more than 1 year ago) 
  • Must not currently require the use of long-term oxygen therapy
  • Must not have a history of alcohol or substance abuse disorder
  • Must be able to attend 16 study visits at the research site over approximately 62 weeks

The research project is testing the safety, tolerability and immunogenicity of intramuscular (into the muscle) injections of a booster vaccine for COVID-19. The new experimental mRNA vaccine is called CV0501. The vaccine is developed by CureVac (a biopharmaceutical company) and GSK (GlaxoSmithKline) Biologicals SA. Key selection criteria:

  • Is a healthy male or nonpregnant female ≥18 years old
  • Not pregnant or breastfeeding
  • Has received at least 2 doses of Comirnaty or Moderna COVID-19 Vaccine (Spikevax®), with the last dose of vaccine received at least 6 months prior to
  • Has NOT received AstraZeneca COVID-19 vaccine. 
  • Negative for SARS-CoV-2 or COVID-19 infection by RT-PCR test at screening
  • Not has a history of documented SARS-CoV-2 infection or COVID-19 within 6 months before screening.
  • Not has a documented medical history of HIV, hepatitis B or hepatitis C infection prior to screening, or a positive test for these conditions at screening.
  • Not has received or plans to receive any licensed vaccine within 4 weeks before or 4 weeks after study vaccination. Inactivated vaccines for influenza are permitted during the study if they are administered at least 14 days before or after study

Then you may be eligible for this study.  If you are interested in finding out more, then please click on the now recruiting link to register your interest.

A national study investigating whether consuming a snack 30 minutes prior to bed is a viable treatment option to improve fasting glucose levels in women with gestational diabetes mellitus (GDM)  – now recruiting If you:

  • Are pregnant and diagnosed with GDM, less than 30 week gestation
  • Singleton pregnancy 

When is the best time to move? This project seeks to determine the feasibility and effectiveness of timing exercise to control blood glucose levels and reduce cardiovascular risk in people with Type 2 Diabetes  – now recruiting If you:

  • Are aged between 40 and 75 years
  • Have a BMI between 27-40kg/ m2
  • HbA1c between 6.5-9.0%
  • Have diabetes treated with lifestyle, oral medications and/or intermediate/long acting inslin
  • Stable weight for previous 3 months (+ 4kgs)
  • Stable medications for previous 3 months

Then you may be eligible for this study.  If you are interested in finding out more, then please click on the now recruiting link to register your interest

A study to test whether the timing of exercise prescription in relation to a glucose-challenge will alter vascular responses and therefore cardiovascular risk If you:

  • Are aged between 25-40 years
  • Have a stable weight for past 3 months (­­+ 4kgs)

Then you may be eligible for this study.  If you are interested in finding out more, then please click on the now recruiting link to register your interest

A study to determine if consuming a moderately low-carbohydrate diet of 90g carbohydrates has a similar effect on blood glucose as consuming either 50g or 130g of carbohydrates. – now recruiting if you:

  • Between the ages of 30-70 years
  • Diagnosed with type 2 diabetes by your physician
  • HbA1c between ~7 – 8.5%
  •  Stable medication and weight for more than 3 months

Then you may be eligible for this study.  If you are interested in finding out more, then please click on the now recruiting link to register your interest.

A study investigating whether timing of physical activity improves glycaemic control in women with gestational diabetes mellitus (GDM) – now recruiting if you:

  • Pregnant with diagnosed GDM, less than 30 weeks’ gestation
  • Singleton pregnancy
  • Not currently prescribed on insulin or metformin

Then you may be eligible for this study.  If you are interested in finding out more, then please click on the now recruiting link to register your interest.

A study testing the thermal hypothesis of RF-EMF (radio-frequency electromagnetic fields) effects on Brain Electrical Activity – now recruiting If you:

  • 18-55 years old with no acute or chronic illness
  • Are right handed
  • Have no history of head injury, concussion, brain tumour, epilepsy or stroke
  • Are not taking prescription medication which acts on the central nervous system 

Then you may be eligible for this study.  If you are interested in finding out more, then please click on the now recruiting link to register your interest.

A study assessing the effect of media communication on risk perception and physiology and investigating whether there is a relationship between short term RF exposure, symptoms and physiology – now recruiting If you:

  • Do not have any acute or chronic illness
  • Are aged between 18-55 years
  • Are of good health and are not currently using pharmaceutical or illicit substances
  • Are sufficiently fluent in English to read and understand the study documentation

Then you may be eligible for this study.  If you are interested in finding out more, then please click on the now recruiting link to register your interest.  

This trial is looking at the correlation between hormone levels and the behaviours and symptoms of depression now recruiting If you:

  • Adult male/ female participants who are currently depressed
  • People of any weight, diet type and level of activity
  • Not using corticosteroids (e.g. asthma puffers) or having a neurological disorder (e.g. epilepsy)
  • Not currently taking antidepressants.
  • People who are likely to be in the local area and available to attend a follow up appointment in 8-12 months

Then you may be eligible for this study.  If you are interested in finding out more, then please click on the now recruiting link to register your interest.

Trials opening soon

Medical Device Trial:  CENOFEX Smart Devices for the Management of Lympheodema: Pilot Feasibility Study If you:

  • Are over 18 years of age
  • Have confirmed lymphoedema
  • Your general health is satisfactory

Then you may be eligible for this study. If you are interested in finding out more, then please click on the now recruiting link to register your interest  

Trials in follow up

  • Shingles Vaccine: Zoster 049 study. A long running trial involving 31,000 people in 18 countries.  Recruitment closed
  • Myovant SPIRIT EXTENSION study: An extension of the SPIRIT 2 study for women with Endometriosis-Associated Pain. Recruitment closed
  • CLEAR – Cardiovascular Study: A study assessing the effects of a new drug on the occurrence of major cardiovascular events in patients who are statin intolerant. Recruitment closed

Supported trials 

The CRTU staff also assist UOW Researchers with their clinical trials by offering their professional services. These Researchers include:

  • Professor Marie Ranson/Senior Research Fellow Kara Perrow – Plasma enzymes as a source of cellular invasive potential
  • Dr Carolyn Dillon – Development of novel therapeutics for the treatment of cancer
  • Professor Ronald Sluyter – In Vitro studies/humanised mice experiments

Past clinical trials

  • Asthma medication study: Using existing medication in a new way to see if asthma management can be improved
  • Over Active Bladder (OAB): Testing safety and tolerability of a new combination of drugs to improve the symptoms of OAB.
  • COMPOSE: A clinical study to assess the safety and potential efficacy of a compound to improve memory, language and learning in people with Down Syndrome.
  • Obesity study: A placebo-controlled weight loss study of an investigational medication.
  • Osteoarthritis study: Assessing the effectiveness of a new drug to relieve pain.
  • Gout study: An evaluation of an investigational drug to see whether, when combined with allopurinol, it reduces high uric acid levels in the blood.
  • Cold sores: Testing an investigational mouth wash to reduce duration of cold sore episodes.
  • Shingles vaccine: A long-running trial involving 31,000 people in 18 countries (the vaccine was shown to be 97 per cent successful in protecting older people from shingles, as reported to the New England Journal of Medicine).
  • Myovant SPIRIT 2 Study: An International Phase 3 Randomised, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a new drug for women with Endometriosis-Associated Pain.
  • Queen Garnet Plum Juice: A randomised controlled trial evaluating the effects of fruit derived anthocyanins for mild cognitive impairment
  • DUPLEX – Renal Study: A randomised, multicentre, double blind, parallel, active control study of a new drug for patients with Primary focal Segmental Glomerulosclerosis (FSGS).
  • ColoSTAT ™️: A simple low cost blood test for the early detection of colorectal cancer.  Developed over 13 years of research by the CSIRO and now being trialled by Rhythm Biosciences
  • Vitamin D and Bone Health Study in Australian Women A landmark study looking at what determines vitamin D status in women by reviewing skin type latitude, diet, and sun exposure
  • Symbiotic Study: SYMptom, microBIOme and dieT in Chronic Kidney disease. A new renal diet designed to improve gut health, diet quality and other clinical outcomes for patients with chronic kidney disease

In the news

Contacts

Clinical Director

A/Professor Bruce Ashford

E: bruceash@uow.edu.au 

c

Clinical Research Program Coordinator

Emma Zhang

T: +61 2 4239 4315

E: emmazh@uow.edu.au