A Double-Blinded, Placebo-Controlled Exploratory Study to Investigate the Efficacy and Safety of Flexible dosing of Oral Lidocaine (ORE-001) to Reduce Abdominal Discomfort and Prevent Early Satiety in Anorexia Nervosa Patients
This study is investigating a new medicine, ORE-001, for people with anorexia nervosa. It aims to see if ORE-001 can help lessen uncomfortable tummy feelings and stop them from feeling full very quickly after eating. Researchers will compare ORE-001 to a placebo (a dummy pill with no active medicine) to understand if it actually helps. They will also check if the medicine is safe to use. The study focuses on how people feel their fullness and stomach discomfort changes over 28 days, and also looks at things like weight, sleep, and overall quality of life. This is an early stage study to explore if the medicine works.
At a glance
What is this study about?
This study is looking into a new medicine called ORE-001 for individuals living with anorexia nervosa. A common challenge for people with anorexia nervosa is experiencing discomfort in their tummy and feeling full very quickly, even after eating a small amount. This study aims to see if ORE-001 can help to reduce these feelings, making it easier to eat and feel more comfortable.
The researchers will compare ORE-001 with a placebo, which is a pill that looks exactly like the study medicine but contains no active ingredients. This helps them to understand if any changes are truly due to the medicine or just because people expect to feel better. They will be observing how participants' feelings of fullness change over 28 days, as well as if their tummy doesn't feel as uncomfortable. This is an exploratory study, meaning it's an early step to find out if ORE-001 has potential benefits and is safe for people to use.
Beyond feelings of fullness and discomfort, the study will also look at other important aspects. This includes changes in body weight, how much food and calories are eaten, sleep patterns, and overall quality of life. The study will also be carefully monitoring for any unwanted effects or side effects from the medication to make sure it is safe.
Key takeaways
- This study is testing a new medicine called ORE-001 for anorexia nervosa.
- It aims to reduce tummy discomfort and common feelings of getting full too quickly.
- Researchers will compare ORE-001 to a dummy pill (placebo).
- It's an early-stage study to check if the medicine works and is safe.
- Only women aged 18 and over with anorexia nervosa can take part.
- You will take tablets and have visits over about 28 days.
Who may be eligible?
This study is looking for women who are at least 18 years old to take part. There isn't an upper age limit mentioned, so older women might also be able to join.
To be eligible, you must have been diagnosed with anorexia nervosa. The study team will check your medical history and current health to make sure the study is a good fit for you.
It's important to remember that there will be other specific health requirements or conditions that might mean you can't join, even if you meet the age and gender criteria. The study doctor will go through all of these in detail with you.
- Are you female?
- Are you 18 years old or older?
- Have you been diagnosed with anorexia nervosa?
- Are you able to attend regular appointments for the study?
- Are you comfortable with the possibility of receiving a dummy pill?
- Are you willing to safely take a new, experimental medicine?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would be given either the study medicine, ORE-001, or a placebo (a dummy pill). You and your doctors wouldn't know which one you are taking – this is called 'double-blinded'. You would take this medicine by mouth, and the dose might be adjusted to find what works best for you ('flexible dosing').
Throughout the study, you would attend regular visits. During these visits, the study team would ask you questions about how you're feeling, especially about any tummy discomfort and how full you feel after eating. You'd likely complete questionnaires, and they would also check your weight and monitor for any side effects from the medicine.
There might be some blood tests to check certain markers in your body. The main part of the study where you take the medication and have assessments would last for 28 days, with some follow-up after that. The total duration of your involvement, including all visits and follow-ups, would be explained to you by the study team.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is anorexia nervosa?
Anorexia nervosa is a serious eating disorder where people maintain an abnormally low body weight, have an intense fear of gaining weight, and a distorted view of their body shape. It can cause many health problems.
What is ORE-001?
ORE-001 is a new medicine being tested. It's a form of lidocaine, which is usually used as a numbing agent, but this study explores if it can help with tummy discomfort and feeling full too quickly in anorexia nervosa.
What does 'double-blinded' mean?
It means that neither you nor the doctors treating you will know if you are receiving the active study medicine (ORE-001) or a dummy pill (placebo). This helps make the study results fair and accurate.
Will I have to stay in hospital?
The information provided doesn't suggest that you would need to stay in hospital for this particular study. It seems to involve taking tablets and attending regular appointments.
What is a 'placebo'?
A placebo is a pill that looks exactly like the study medicine but doesn't contain any active drug. It's used to compare against the real medicine to see if the medicine itself is causing any effects.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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