In short
A clinical trial is underway to assess the effectiveness and safety of Naronapride Dihydrochloride Trihydrate, a potential treatment for moderate idiopathic or diabetic gastroparesis. This phase IIb study aims to determine the optimal dose and evaluate the drug's impact on symptoms associated with delayed stomach emptying. The trial involves a 12-week treatment period and compares the effects of Naronapride to a placebo in adult participants.
At a glance
- Drug Name
- Naronapride Dihydrochloride Trihydrate
- Trial Phase
- Phase IIb
- Condition Studied
- Moderate idiopathic or diabetic gastroparesis
- Main Objective
- Evaluate efficacy of 12-week treatment compared to placebo
- Secondary Objectives
- Determine optimal dose, evaluate safety and tolerability
- Participant Age Range
- 18-75 years
- Treatment Duration
- 12 weeks
- Drug Form
- Film-coated tablet (oral)
- Primary Endpoint
- Change in average weekly total symptom score
What is Naronapride?
Naronapride, also known by its chemical name naronapride dihydrochloride trihydrate or the synonym ATI-7505 dihydrochloride trihydrate, is a medication currently being studied for the treatment of gastroparesis. It is being developed as a film-coated tablet for oral use, which means it's a pill that you would swallow.
What is Gastroparesis?
Gastroparesis is a condition where the stomach takes too long to empty its contents. It can be caused by diabetes (diabetic gastroparesis) or have no known cause (idiopathic gastroparesis). Symptoms of gastroparesis can include nausea, early feeling of fullness when eating, feeling overly full after eating, upper abdominal pain, vomiting, and bloating.
How Naronapride Works
Naronapride is classified as a receptor agonist. This means it's designed to bind to specific receptors in your body and activate them. In the case of gastroparesis, it's likely that Naronapride aims to stimulate the muscles in your digestive system to help move food through your stomach more quickly.
Current Research on Naronapride
Naronapride is currently being studied in a Phase 2b clinical trial. This is an important step in determining if the drug is safe and effective for treating gastroparesis. The main goals of this study are:
- To see if Naronapride can improve the symptoms of gastroparesis compared to a placebo (a pill with no active ingredient) over a 12-week treatment period.
- To find out what dose of Naronapride works best for treating gastroparesis.
- To evaluate the safety and tolerability of Naronapride.
Who Can Participate in the Study?
The study is looking for participants who meet certain criteria. These include:
- Men and women between 18 and 75 years old
- People who have had symptoms of idiopathic or diabetic gastroparesis for at least 3 months
- Evidence of delayed stomach emptying
- A certain level of symptom severity
- Body Mass Index between 16 and 35 kg/m2
There are also certain conditions that would prevent someone from participating in the study, such as having had major gastrointestinal surgery or having certain other digestive conditions.
What to Expect During the Study
If you participate in the study, you would be randomly assigned to receive either Naronapride or a placebo for 12 weeks. The study is "double-blind," which means neither you nor the researchers would know which one you're receiving.
Throughout the study, you would be asked to track your symptoms. The researchers will be looking at how your symptoms change from the beginning to the end of the treatment period.
Potential Benefits and Risks
While the potential benefits of Naronapride are still being studied, the hope is that it could improve symptoms of gastroparesis such as nausea, feeling full quickly, upper abdominal pain, vomiting, and bloating.
As with any medication, there may be risks or side effects. Part of the purpose of this study is to better understand these potential risks. If you're considering participating in a clinical trial, it's important to discuss the potential risks and benefits with your doctor and the research team.