RecruitingPHASE3INTERVENTIONAL

Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

This study is investigating a new medication, tradipitant, for people suffering from gastroparesis. Gastroparesis is a condition where the stomach empties food too slowly, often causing nausea and discomfort. This particular study focuses on people whose gastroparesis is linked to diabetes, or where the cause isn't known (idiopathic). It's an 'open-label' study, meaning both you and the study team will know you are taking tradipitant. The main goal is to find out how safe tradipitant is when taken over a three-month period. It's a Phase 3 study, which means it’s one of the final steps before a medicine might be approved for wider use, looking closely at safety in a larger group of patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Vanda Pharmaceuticals

Enrolment target

100

Start

09 Jan 2024

Estimated completion

01 Dec 2025

Idiopathic Gastroparesis Diabetic Gastroparesis Gastroparesis

What is this study about?

This study is testing a medicine called tradipitant for a condition known as gastroparesis. Gastroparesis means your stomach empties much more slowly than it should. This can lead to symptoms like feeling very sick (nausea), throwing up, feeling full very quickly, and discomfort in your tummy. We're looking at people who have gastroparesis because of diabetes, or where doctors can't find another clear reason for it (this is called idiopathic gastroparesis).

The main aim of this study is to carefully look at how safe tradipitant is when people take it for three months. To do this, doctors will monitor participants closely and record any side effects. This is a "Phase 3" study, which means it's a key stage in developing a new medicine. At this point, doctors are keen to gather more safety information from a larger group of people before it could potentially be made available to more patients.

By taking part, you would be helping researchers understand more about tradipitant and whether it could be a helpful treatment option for people living with gastroparesis in the future. Your involvement could make a real difference in advancing our understanding of this condition and its potential treatments.

Key takeaways

The study is testing a new medicine, tradipitant, for gastroparesis.
It aims to find out how safe tradipitant is over three months.
It's for people with gastroparesis caused by diabetes or for no known reason.
You would receive the active drug, and doctors would closely monitor your health.
The study lasts several months, with three months of treatment.
Your participation could help develop new treatments for gastroparesis.

Who may be eligible?

To be considered for this study, you would need to have a confirmed diagnosis of gastroparesis and doctors would need to have shown that your stomach empties too slowly. You should also be experiencing moderate to severe (noticeable and bothersome) feelings of sickness or nausea. Your body mass index (BMI), which is a measure of your weight in relation to your height, should be between 18 and 40.

There are some reasons why you might not be able to join. For example, if you have another illness or are taking other treatments that could be causing your gastroparesis symptoms, or if you test positive for certain drugs. If you are pregnant or breastfeeding, you won't be able to take part. Also, if your blood sugar levels are poorly controlled (for example, if your HbA1c, a measure of average blood sugar, is very high) or if you've had a serious diabetes-related health problem recently, you wouldn't be able to join this particular study.

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.

Have you been diagnosed with gastroparesis?
Has it been shown that your stomach empties slowly?
Do you get moderate to severe feelings of sickness (nausea)?
Is your BMI (body weight in relation to height) between 18 and 40?
Are you not pregnant or breastfeeding?
Is your diabetes (if you have it) generally well-controlled?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study medicine, tradipitant, for three months. Because it's an 'open-label' study, both you and the doctors will know you are taking the active medicine. You will have regular visits to the clinic so the study team can monitor your health, check for any side effects, and see how you are responding to the treatment. These visits will involve health checks, asking about your symptoms, and possibly blood tests or other assessments. After the three months of treatment, there will likely be a follow-up visit to make sure you are well. The total time you would be involved in the study, including screening, treatment, and follow-up, would last a few months.

Potential risks and benefits

Taking part in a clinical study might offer potential benefits, such as receiving a new treatment that isn’t widely available yet and having your health closely monitored by a specialist team. However, there are also potential risks involved. The medicine might cause side effects, which could be mild or more serious, and it might not improve your gastroparesis symptoms. You will be fully informed of all known risks before deciding to take part. Remember, joining a study is always your choice, and you are free to withdraw at any time, for any reason, without affecting your usual medical care.

Locations (3)

Vanda Investigational Site
Verified postcode
Leuven, Belgium· Recruiting
Vanda Investigational Site
Verified postcode
Liège, Belgium· Recruiting
Vanda Investigational Site
Verified postcode
Leipzig, Germany· Recruiting

Common questions

What is gastroparesis?

Gastroparesis is a condition where your stomach empties food much slower than it should, which can cause sickness, vomiting, and feeling full quickly.

What is tradipitant?

Tradipitant is the name of the new medicine being tested in this study for gastroparesis.

What does 'open-label' mean?

It means both you and the study doctors will know that you are receiving the active study medication, tradipitant.

How long does the study last?

You would take the medicine for three months, and the total study involvement, including check-ups, would last a few months.

Will I get help with travel costs?

This is a good question to ask the study team when you speak to them, as policies can vary between different study sites.

How to find out more

Vanda Pharmaceuticals

clinicaltrials@vandapharma.com 202-734-3400 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.