Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Double-blind, randomised, placebo-controlled, dose-finding phase IIb trial to evaluate the efficacy, safety, and tolerability of a 12-week-treatment with Naronapride in adult participants with at least moderate idiopathic or diabetic gastroparesis

This research study is looking at a new medicine called Naronapride. It's for adults who have a condition called gastroparesis, where their stomach empties food too slowly. This can cause uncomfortable symptoms like feeling sick (nausea), bloating, and feeling full very quickly. The study aims to find out if Naronapride can help reduce these symptoms and improve how people feel. We also want to check if the medicine is safe and if different doses work better. Some participants will receive the new medicine, while others will receive a placebo (a dummy pill with no active ingredient) to compare the results fairly. The study will last for 12 weeks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Dr. Falk Pharma GmbH

Enrolment target

202

Start

01 Aug 2024

Idiopathic or Diabetic Gastroparesis

What is this study about?

This study is a clinical trial, which means it's a carefully planned research study to test new medicines or treatments. In this particular study, we're focusing on a condition called gastroparesis. If you have gastroparesis, your stomach takes too long to empty food into your small intestine. This can lead to a number of unpleasant symptoms, such as feeling sick (nausea), throwing up, feeling full after eating only a small amount, bloating, and tummy pain.

There are different reasons why someone might get gastroparesis. In some cases, doctors aren't sure why it happens, which is called 'idiopathic' gastroparesis. In other cases, it can be a complication of diabetes, known as 'diabetic' gastroparesis. This study is open to adults who have either of these types of gastroparesis.

The main goal of this study is to see if a new medicine, called Naronapride, can help people with gastroparesis feel better. We want to find out if it can reduce their symptoms and improve their daily lives. We will be carefully monitoring participants to see how their symptoms change over time and also to check for any side effects, making sure the medicine is safe.

Key takeaways

This study is testing a new medicine called Naronapride for gastroparesis symptoms.
It's for adults (18+) with idiopathic or diabetic gastroparesis.
Participants will receive either Naronapride or a placebo for 12 weeks.
The main goal is to see if Naronapride reduces symptoms like nausea and bloating.
Safety is also a key part of the study.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

The most important thing is that you have been diagnosed with gastroparesis, either 'idiopathic' (meaning the cause isn't known) or 'diabetic' (meaning it's linked to your diabetes). The study is specifically looking for people whose gastroparesis symptoms are at least 'moderate', meaning they cause a noticeable impact on your daily life.

There will be other specific health requirements that the study doctors will discuss with you. These are in place to make sure the study is safe for you and that the results are clear.

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 your gastroparesis symptoms at least moderate?
Are you able to attend regular clinic visits for 12 weeks?
Are you willing to potentially receive a placebo (dummy pill)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given one of four study treatments. Three of these will be different strengths of the new medicine (Naronapride), and one will be a 'placebo' (a dummy pill that looks the same but has no active medicine). You won't know whether you're receiving the active medicine or the placebo, and neither will the study doctors. This helps us to get the most accurate results.

The treatment will last for 12 weeks. During this time, you will take the study tablets regularly. You'll have several visits to the study clinic (called 'visit 2' through to 'visit 6') where doctors and nurses will check on your health and how you're feeling. They will ask you to keep track of your symptoms, such as nausea, bloating, and pain, to see if the medicine is making a difference. These regular check-ups help us understand if the medicine is working and if it's safe for you.

Potential risks and benefits

Participating in a study like this might offer potential benefits, such as access to a new medicine that could improve your gastroparesis symptoms before it's widely available. You'll also receive careful medical monitoring. However, there are potential risks, including side effects from the study medicine or the possibility that the medicine might not help you. You might also receive the placebo, which means you won't get the active treatment. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Austria
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Unverified
Belgium
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Unverified
Netherlands
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Unverified
Germany
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Unverified
Poland
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Unverified
France
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Unverified
Latvia

Common questions

What is gastroparesis?

Gastroparesis is a condition where your stomach takes too long to empty its contents into your small intestine, leading to symptoms like nausea, vomiting, bloating, and feeling full quickly.

What is a placebo?

A placebo is a 'dummy pill' that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the active medicine fairly.

How long will the study last?

The treatment part of the study will last for 12 weeks. You'll have several visits to the clinic during this time.

Will I know if I'm getting the real medicine?

No, you won't know if you're receiving the active medicine or the placebo, and neither will the study doctors. This is called 'double-blind' and helps ensure fair results.

What are 'idiopathic' and 'diabetic' gastroparesis?

Idiopathic means the cause of your gastroparesis isn't known, while diabetic means it's linked to your diabetes.