Ongoing Clinical Trials for Diabetic Gastroparesis
There are currently 2 ongoing clinical trials investigating new treatments for diabetic gastroparesis, a condition where the stomach takes too long to empty its contents due to diabetes-related nerve damage. These trials are testing two different medications – tradipitant and naronapride – across multiple countries in Europe, aiming to evaluate their safety and effectiveness in reducing symptoms such as nausea, vomiting, and abdominal discomfort.
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 testing a medication called tradipitant, which is taken as a capsule. The study focuses on patients who experience moderate to severe nausea due to gastroparesis, whether caused by diabetes or having no known cause.
Who can participate: Adults between 18 and 70 years old who have been diagnosed with gastroparesis and experience moderate to severe nausea. Participants must have had nausea symptoms for at least 6 months and show evidence of delayed stomach emptying confirmed by medical tests within the past 10 years. The condition must persist despite changes in diet or lifestyle. Participants need to have a Body Mass Index between 18 and 40 kg/m², which is a measure of body fat based on height and weight. Those capable of having children must agree to use contraception during the study. All participants must be willing to keep a daily symptom diary, avoid certain medications, and manage blood sugar levels if they have diabetes.
Who cannot participate: Patients who do not experience moderate to severe nausea, those outside the specified age range, and individuals from vulnerable populations such as children, pregnant women, or those unable to provide consent cannot join this trial.
What the trial aims to do: The main goal is to evaluate the safety of tradipitant over a three-month period. Researchers will monitor participants for any side effects, including changes in mood or behavior, and will regularly check vital signs, laboratory test results, heart function through electrocardiograms, and overall physical health.
How tradipitant works: Tradipitant is a neurokinin-1 receptor antagonist, which means it blocks a specific receptor in the brain involved in the vomiting reflex. This mechanism may help reduce nausea in patients with gastroparesis. The medication is taken orally, and participants will follow it for three months while maintaining a daily symptom diary.
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 if it can improve symptoms in adults with moderate gastroparesis. The study includes both diabetic and idiopathic forms of the condition.
Who can participate: Men and women aged 18 to 75 years who have experienced main symptoms of gastroparesis for at least 3 months. 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 test must confirm there are no mechanical obstructions, narrowing of passages, structural diseases, or stomach ulcers.
Who cannot participate: Pregnant or breastfeeding women, individuals with severe allergies to the study medication, those with other significant stomach or intestinal diseases, people who recently had major stomach or intestinal surgery, those currently using certain medications affecting stomach movement, individuals with uncontrolled diabetes, patients with severe kidney or liver problems, people with a history of alcohol or drug abuse in the past year, individuals with certain heart conditions such as irregular heartbeats, and those who participated in another clinical trial within the last 30 days are all excluded.
What the trial aims to do: 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 goals include evaluating improvements in specific symptoms such as nausea, early satiety (feeling full quickly), postprandial fullness (feeling full after meals), upper abdominal pain, vomiting episodes, and bloating. The study is double-blind, meaning neither participants nor researchers know who receives the actual medication versus a placebo, ensuring unbiased results.
How naronapride works: Naronapride is a prokinetic agent that enhances gastrointestinal motility. It works at the molecular level as a serotonin 5-HT4 receptor agonist, which stimulates the release of neurotransmitters that increase muscle contractions in the gastrointestinal tract. This mechanism may help the stomach empty more effectively, reducing symptoms associated with gastroparesis.
Summary
Both ongoing clinical trials for diabetic gastroparesis are being conducted across multiple European countries, with Germany and Belgium hosting both studies. The naronapride trial has broader geographic reach, spanning eight countries including Austria, France, Italy, Latvia, Netherlands, and Poland, in addition to Germany and Belgium.
The two trials take different approaches to treating gastroparesis. Tradipitant focuses primarily on safety evaluation and targets the nausea symptom by blocking receptors in the brain involved in the vomiting reflex. In contrast, naronapride aims to improve overall stomach function by enhancing muscle contractions in the digestive tract, potentially addressing multiple symptoms simultaneously. The naronapride study includes a placebo control group and evaluates both effectiveness and safety, while the tradipitant trial concentrates specifically on safety monitoring over three months.
These trials represent important steps in finding better treatment options for people living with diabetic gastroparesis, a condition that can significantly impact quality of life and make diabetes management more challenging.