In short
There are currently 2 ongoing clinical trials investigating new treatments for impaired gastric emptying, a condition where the stomach cannot empty food properly. These studies are taking place across multiple European countries and are testing medications called tradipitant and naronapride in patients with idiopathic or diabetic gastroparesis. (Also known as: Gastroparesis, Delayed Gastric Emptying)
Clinical trial locations
- Austria
- Belgium
- France
- Germany
- Italy
- Latvia
- Netherlands
- Poland
Safety Study of Tradipitant for Patients with Idiopathic or Diabetic Gastroparesis
This trial is examining the safety of tradipitant, a medication taken as a capsule, in patients who have gastroparesis with moderate to severe nausea. The study includes people whose gastroparesis has no known cause (idiopathic) or is related to diabetes. The treatment period lasts three months, during which participants will be carefully monitored for any side effects or health changes.
Inclusion criteria: Participants must be between 18 and 70 years old and have been diagnosed with idiopathic or diabetic gastroparesis with moderate to severe nausea. They must have experienced delayed stomach emptying confirmed by medical tests within the past 10 years, and their nausea symptoms must have lasted at least 6 months before joining the study. Symptoms should persist despite dietary or lifestyle changes. Participants need to have a Body Mass Index between 18 and 40 kg/m², be willing to use contraception if able to have children, and agree to keep a daily symptom diary while avoiding certain medications.
Exclusion criteria: Patients who do not experience moderate to severe nausea, are outside the specified age range, or belong to vulnerable populations such as children, pregnant women, or those unable to provide consent cannot participate in this study.
Focus of the trial: The main goal is to evaluate the safety of tradipitant over three months. Researchers will monitor participants for adverse events, changes in mood or behavior, vital signs, laboratory results, heart function through electrocardiograms, and overall physical health. Participants will keep daily records of their symptoms throughout the study period.
Investigational drug: Tradipitant is a neurokinin-1 receptor antagonist that works by blocking a specific receptor in the brain involved in the vomiting reflex. It is taken orally as a tablet and is being evaluated for its ability to help manage nausea in patients with gastroparesis.
Study on the Safety and Effectiveness of Naronapride for Adults with Moderate Idiopathic or Diabetic Gastroparesis
This trial is studying naronapride, a medication taken as a film-coated tablet, to see how well it works in treating symptoms of gastroparesis and whether it is safe and well-tolerated. The study focuses on adults with moderate symptoms of either idiopathic or diabetic gastroparesis. This is a double-blind trial lasting 12 weeks, meaning neither participants nor researchers will know who receives the actual medication or a placebo.
Inclusion criteria: Participants must be between 18 and 75 years old and have experienced main symptoms of idiopathic or diabetic gastroparesis for at least 3 months. They must show evidence of delayed gastric emptying and have an average weekly symptom score of 2.0 or higher. Their Body Mass Index must be between 16 and 35 kg/m². An upper gastrointestinal endoscopy or imaging must confirm there are no mechanical obstructions, narrowing of passages, structural diseases, or stomach ulcers.
Exclusion criteria: The study 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 had recent major stomach or intestinal surgery. Participants currently using certain medications affecting stomach movement, those with uncontrolled diabetes, severe kidney or liver problems, certain heart conditions, or a history of alcohol or drug abuse in the past year cannot join. Those who participated in another clinical trial within the last 30 days are also excluded.
Focus of the trial: The primary goal is to assess changes in the average weekly total symptom score from the beginning to the end of the 12-week treatment period. Secondary evaluations include measuring changes in specific symptoms such as nausea, feeling full quickly after eating, feeling full after meals, upper abdominal pain, vomiting episodes, and bloating. The study aims to find the optimal dose that provides the best balance of effectiveness and safety.
Investigational drug: Naronapride is a prokinetic agent that works as a serotonin 5-HT4 receptor agonist. It enhances gastrointestinal movement by stimulating the release of neurotransmitters that increase muscle contractions in the digestive tract. The medication is taken orally in tablet form and is being studied for its potential to alleviate symptoms of gastroparesis.
Summary
Both ongoing clinical trials for impaired gastric emptying are focused on patients with idiopathic or diabetic gastroparesis who experience significant symptoms. The trials are investigating two different approaches: tradipitant, which targets the vomiting reflex through the brain, and naronapride, which enhances stomach muscle contractions directly. Notably, the naronapride study has a broader geographic presence across eight European countries compared to the tradipitant study, which is conducted in Belgium and Germany. The tradipitant trial emphasizes safety monitoring over a three-month period, while the naronapride study evaluates both safety and effectiveness over 12 weeks using a placebo-controlled design. Both studies require participants to have documented delayed gastric emptying and persistent symptoms despite lifestyle modifications, reflecting the challenging nature of managing this condition.
