A MULTICENTER OPEN LABEL 3 MONTH SAFETY STUDY WITH TRADIPITANT IN PATIENTS WITH IDIOPATHIC OR DIABETIC GASTROPARESIS
This study is investigating a new medication called tradipitant. It's for people who suffer from gastroparesis, a condition where the stomach empties too slowly, causing symptoms like severe sickness. The main goal is to understand how safe tradipitant is when given to patients with gastroparesis, whether it's caused by diabetes or for unknown reasons. Researchers will closely monitor for any side effects, including serious ones, and check vital signs, blood tests, heart readings (ECGs), and general physical health over a three-month period. This is an important step to make sure the medicine is safe before it can be widely used.
At a glance
What is this study about?
This research study is focused on a health condition called gastroparesis. If you have gastroparesis, your stomach doesn't empty its contents into your small intestine as quickly as it should. This can lead to very uncomfortable symptoms, especially feeling sick to your stomach (nausea) and vomiting, which can be quite severe. Gastroparesis can happen on its own (idiopathic) or it can be a complication for people with diabetes. This study specifically welcomes people with either type of gastroparesis who are experiencing moderate to severe nausea.
The study is testing a new medicine called tradipitant. The goal isn't to see if the medicine works to stop the gastroparesis symptoms in this particular study, but rather to carefully check how safe it is for people to take. Researchers want to understand if there are any side effects, how strong they might be, and how the medicine affects different parts of the body. This is a very important stage in developing new medicines, as patient safety is always the top priority.
Over a three-month period, participants will be given tradipitant. During this time, the medical team will regularly check your overall health. This includes looking for any new or worsening health problems (called adverse events), checking things like your blood pressure and heart rate (vital signs), doing blood tests, taking recordings of your heart's electrical activity (ECGs), and performing general physical examinations. They will also pay close attention to any thoughts or feelings about self-harm, as personal well-being is crucial.
Key takeaways
- The study is for adults with gastroparesis and severe sickness.
- It's testing the safety of a new medicine called tradipitant.
- You'll be monitored closely for three months with regular health checks.
- This is an important step to ensure patient safety for new medicines.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, adult patients of any age can take part – from 18 years old and up. Both men and women are welcome to participate. The study is open to a broad range of adults.
However, it's important that you have been diagnosed with gastroparesis, which means your stomach empties too slowly. This condition can be either 'idiopathic' (meaning the cause isn't known) or 'diabetic' (meaning it's related to diabetes). A key requirement is that you are currently experiencing moderate to severe sickness (nausea) as a symptom of your gastroparesis.
There might be other specific health checks or conditions that would mean you couldn't take part, but these details would be discussed fully with you by the study doctor. They need to ensure the study is safe and appropriate for everyone involved.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with gastroparesis (either idiopathic or diabetic)?
- Are you currently experiencing moderate to severe sickness (nausea) due to your gastroparesis?
- Are you available for regular clinic visits and health checks over approximately three months?
What does participation involve?
If you decide to take part, you'll be given the study medicine, tradipitant, for three months. Throughout these three months, you’ll have regular visits to the clinic or hospital. During these visits, the study team will carry out various checks including measuring your blood pressure and heart rate, taking blood and urine samples for lab tests, performing heart recordings (ECGs), and doing general check-ups. They will also talk with you about how you're feeling and whether you've experienced any side effects. The exact number of visits and tests will be explained to you in detail by the study team, along with how long each visit might last. You will also have a follow-up period after the three months of taking the medicine to ensure your health is stable. The total duration of your involvement, including follow-up, will be clearly outlined.
Potential risks and benefits
Locations (2)
- —UnverifiedBelgium
- —UnverifiedGermany
Common questions
What is gastroparesis?
It's a condition where your stomach empties food into your intestines slower than it should, often causing severe sickness and vomiting.
What is tradipitant?
It's a new medicine being tested in this study to see how safe it is for people with gastroparesis.
Will this medicine cure my gastroparesis?
This study is mainly looking at the safety of tradipitant, not whether it cures gastroparesis or stops all symptoms. That would be looked at in later studies.
How long will I be in the study?
You'll take the medicine for three months, and there will be follow-up checks afterwards. The total time will be explained by the study team.
Can I stop participating if I want to?
Yes, you can leave the study at any time, for any reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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