In short
Two clinical trials are currently investigating new medications for diabetic gastroparesis, a condition where the stomach empties too slowly in people with diabetes. These studies are testing tradipitant and naronapride to see if they can safely and effectively improve symptoms like nausea, vomiting, and feeling full too quickly. Trials are taking place across several European countries, offering opportunities for eligible patients to access experimental treatments.
Clinical trial locations
- Austria
- Belgium
- France
- Germany
- Italy
- Latvia
- Netherlands
- Poland
Safety Study of Tradipitant for Patients with Idiopathic or Diabetic Gastroparesis
This clinical trial is investigating tradipitant, a medication taken as a capsule, for patients experiencing moderate to severe nausea related to gastroparesis. The study focuses on understanding how safe this treatment is when taken over a three-month period.
Who can participate: The study is looking for adults between 18 and 70 years old who have been diagnosed with gastroparesis and continue to experience nausea despite making changes to their diet or lifestyle. Participants must have confirmed delayed stomach emptying through medical testing within the past 10 years and must have experienced nausea symptoms for at least six months before joining. A Body Mass Index between 18 and 40 kg/m² is required. Those who can have children must agree to use contraception during the study, and all participants must be willing to keep a daily symptom diary and avoid certain medications.
Who cannot participate: The trial excludes people who do not experience moderate to severe nausea, those outside the specified age range, and members of vulnerable populations such as children, pregnant women, or individuals unable to provide consent.
Study focus: The main goal is to evaluate the safety of tradipitant by monitoring participants for any side effects or health changes over three months. This includes tracking vital signs, laboratory test results, heart function through electrocardiograms, and overall physical health. The medication works by blocking a specific receptor in the brain called the neurokinin-1 receptor, which is involved in triggering nausea and vomiting.
Investigational drug: Tradipitant is an oral medication classified as a neurokinin-1 receptor antagonist. It is being tested specifically for its safety in managing nausea symptoms in gastroparesis patients.
Study on the Safety and Effectiveness of Naronapride for Adults with Moderate Idiopathic or Diabetic Gastroparesis
This trial is examining naronapride, a film-coated tablet medication, to determine both its effectiveness and safety in treating gastroparesis symptoms over a 12-week period. The study is designed as a double-blind trial, meaning neither participants nor researchers know who receives the actual medication or a placebo.
Who can participate: Adults aged 18 to 75 who have experienced symptoms of gastroparesis for at least three months are eligible. Participants must show evidence of delayed stomach emptying and have an average weekly symptom score of 2.0 or higher, which measures symptom severity. Body Mass Index must be between 16 and 35 kg/m². An upper gastrointestinal endoscopy or imaging must confirm that there are no physical blockages, narrowing of passages, or stomach ulcers present.
Who cannot participate: The trial excludes pregnant or breastfeeding women, individuals with severe allergies to the study medication, those with other significant stomach or intestinal diseases, and people who have recently had major stomach or intestinal surgery. Participants with uncontrolled diabetes, severe kidney or liver problems, certain heart conditions, or a recent history of alcohol or drug abuse are also excluded. Additionally, those currently using medications that affect stomach movement or who participated in another clinical trial within the last 30 days cannot join.
Study focus: The research aims to assess whether naronapride can reduce the overall symptom severity score and improve specific symptoms such as nausea, feeling full quickly after eating, feeling full after meals, upper abdominal pain, vomiting episodes, and bloating. Researchers will compare these results between participants receiving naronapride and those receiving the placebo. The medication enhances stomach muscle movement by acting as a serotonin 5-HT4 receptor agonist, which stimulates the release of chemicals that increase muscle contractions in the digestive tract.
Investigational drug: Naronapride is classified as a prokinetic agent, meaning it helps speed up stomach emptying. It is administered orally in tablet form and is currently in a phase IIb trial to evaluate its potential for treating gastroparesis symptoms.
Summary
Currently, two clinical trials are actively recruiting patients with diabetic gastroparesis in Europe. These studies represent different approaches to managing this challenging condition. The tradipitant trial focuses primarily on safety evaluation, monitoring patients for three months to ensure the medication is well-tolerated. Meanwhile, the naronapride trial takes a broader approach, examining both safety and effectiveness over 12 weeks while comparing results against a placebo group.
Geographically, the naronapride study has a wider reach, operating in eight European countries including Germany, Poland, France, Latvia, Belgium, Netherlands, Italy, and Austria. The tradipitant study is limited to Belgium and Germany. This broader distribution of the naronapride trial may offer more opportunities for patients across Europe to participate.
Both medications work through different mechanisms. Tradipitant targets nausea by blocking brain receptors involved in the vomiting reflex, while naronapride works by enhancing stomach muscle contractions to improve emptying. These complementary approaches reflect ongoing efforts to find effective treatments for the various symptoms associated with gastroparesis. Patients interested in participating should discuss eligibility requirements with their healthcare providers.
