Study Information for Participants: Exploring Potential New Ways to Manage Pain and Inflammation During Gout Flare-Ups
What is the purpose of this study?
Where is my nearest study site?
What is the purpose of this study?
This study aims to evaluate the safety and tolerability of a new treatment (NOV-1776) for the pain associated with gout flare-ups that is applied topically to only the affected area, to find out what effects it has on adult gout patients.
Where is my nearest study site?
Here is a list of all of the sites who are currently recruiting for this study:
- Paratus Clinical Research Central Coast
654 Pacific Highway, Central Coast New South Wales 2259 - Linear Clinical Research
1 Hospital Avenue, B-Block, 1st Floor, Nedlands Western Australia 6009
Who can participate?
To take part in this study, you will need to meet all the following (other criteria apply):
- Be aged between 18-70, inclusive
- Have a medical diagnosis of gout. If medical records are not available, gout may be diagnosed at the first pre-screening. For gout patients currently experiencing a gout flare, the Investigator provides medical diagnosis.
- Have had a minimum of 2 gout flare-ups in the last 15 months
- Have a Body mass index (BMI) between 18.0 to 40.0 and body weight of at least 50 kg.
Who cannot participate?
Unfortunately, if any of the following apply to you, this study is not the right fit for you:
- Gout patients who experience gout flares only in the hands and wrists.
- Have uncontrolled hypertension with consistent blood pressure higher than
140 / 90 mmHg. - Have an allergy or sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) or ketorolac tromethamine or a history of significant allergies and hypersensitivity reactions to aspirin or any other medications, either prescription or nonprescription, including dietary supplements or herbal medications.
- Have a history or recent occurrence of clinically significant skin disorders including photosensitivity reactions, eczema, and psoriasis.
Please note, additional eligibility criteria apply and will be discussed in a phone call
with our team.
What is involved?
If you are deemed eligible for the study, your participation is expected to last approximately 10 days (with the exception of the time awaiting acute gout flare-up symptoms to begin) , and you will be required to attend the study site at least 3 times, but could be up to five times. This includes:
- A short pre-screening visit for those participants who do not have documentation of their gout medical diagnosis.
- Initial visit to the study site to determine eligibility for the study
- Day 1 visit to the study site for initial treatment and to receive medication for subsequent treatment at home.
- Day 6 visit to the study site for initial follow up assessment.
- Day 8 visit to the study site to complete follow up assessments.
Participation in this research is voluntary, and you may withdraw from the study at any time.
If you take part in the research study, there will be:
- Reimbursement of costs or Payment for your time: This study provides reimbursement or payment options to support participants, such as covering travel or time spent. Specific arrangements will be communicated to you by the study team.
- Free study-related medical care: Be among the first to access potential new research treatments before they are widely available.
- Expert medical monitoring: Receive top-tier medical care and monitoring from experienced healthcare professionals.
- Contribution to medical research: Your participation in this study is important. By participating you will be contributing to potential advances in medicine that may ultimately provide better treatments in the future, for people who suffer from painful gout symptoms.
What is gouty flare?
Acute gouty flare is a serious debilitating condition causing excruciating pain with an unmet medical need. Despite several drugs on the market to manage chronic gout prophylactically, patients still suffer on average, one to three acute gout flare-ups every year that last for 5-7 days (Neogi 20061). There are ~41.2 million people globally who suffer from gout. While the Australasia region (region consisting of Australia, New Zealand, New Guinea, and the neighbouring islands of the Pacific Ocean) has about 0.6 million gout sufferers, it is a region with the highest global incidence rate of gout. Within Australasia, there are approximately 7.2 million acute gouty flare-up days annually (Safiri 20202).
Acute gouty flare is an intensely painful and disabling inflammatory arthritis, usually involving a single joint but occasionally involving two or more joints. Without therapy, the gout flare usually resolves completely within a few days to several weeks, particularly in early disease. However, symptoms improve more quickly with administration of any of a broad array of anti-inflammatory drugs. Upon resolution of a gout flare, the patient is said to have entered a symptom-free period. However, flares recur in the great majority of
patients; with more frequent episodes, flares may be more severe and prolonged, with consequent shortening of asymptomatic periods.
1. Neogi, Tuhina, Hunter, David J., Chaisson, Christine E., Allensworth-Davies, Donald, Zhang, Yuqing. Frequency and Predictors of Inappropriate Management of Recurrent Gout Attacks in a Longitudinal Study. The Journal of Rheumatology. 2006; 33:1, pp. 104-109.
2. Safiri, Saeid, Kolahi, Ali-Asghar, Cross, Marita, Carson-Chahhoud, Kristin, Hoy, Damian, Almasi-Hashiani, Amir, Sepidarkish, mahdi, Ashrifi-Asgarabad, Ahad, Moradi-Lakeh, Maziar, Mansournia, Mohammad Ali, Kaufman, Jay S., Collins, Gary, Woolf, Anthony D., March, Lyn, Smith, Emma. Prevalence, Incidence, and Years Lived With Disability Due To Gout And Its Attributable Risk Factors for 195 Countries and Territories 1990-2017: A Systematic Analysis Of The Global Burden Of Disease Study 2017. Arthritis & Rheumatology. Vol 72, No. 11, November 2020, pp. 1916-1927.
Why is this study important?
The main aim of treating a gout flare-up is to quickly and safely relieve pain and discomfort. Right now, the primary treatment is a group of drugs called NSAIDs (non-steroidal anti-inflammatory drugs), which reduce inflammation throughout the body. However, these drugs can cause serious side effects and are generally not recommended for older adults with other health issues, like stomach problems, bleeding disorders, or reduced kidney function. Overall, these current treatments for sudden gout flare-ups may not work well for everyone and often come with significant risks.
The study could potentially offer a local treatment of pain and inflammation in patients with gouty flares without the risks of systemic side effects, and provide an option to gout patients with known gastrointestinal issues.
Who is involved?
This study is being sponsored by Novilla Pharmaceuticals, Pty. Ltd., a biotechnology company working to develop groundbreaking therapeutics that bypass the most common route of administration- the bloodstream- so that effective therapeutics can be delivered to a site of action while avoiding exposure to the rest of the body. Novilla strives to deliver effective pain therapeutics locally to avoid systemic side effects.
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This trial has been approved by an independent ethics committee
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