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Study on the Safety and Effectiveness of Naronapride for Adults with Moderate Idiopathic or Diabetic Gastroparesis

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as gastroparesis, which is a disorder that affects the normal movement of the stomach muscles, leading to delayed stomach emptying. The study specifically looks at two types of this condition: idiopathic gastroparesis, where the cause is unknown, and diabetic gastroparesis, which occurs in people with diabetes. The treatment being tested is a medication called Naronapride, which is taken as a film-coated tablet. The purpose of the study is to evaluate the effectiveness, safety, and tolerability of Naronapride in treating symptoms of gastroparesis over a 12-week period.

Participants in the study will be randomly assigned to receive either the Naronapride tablets or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The trial aims to find the optimal dose of Naronapride that provides the best balance of effectiveness and safety for patients with gastroparesis.

Throughout the study, participants will be monitored for changes in their symptoms, such as nausea, early satiety (feeling full quickly), postprandial fullness (feeling full after meals), upper abdominal pain, vomiting episodes, and bloating. The goal is to see if Naronapride can improve these symptoms compared to the placebo. The study will last for 12 weeks, during which participants will have regular check-ups to assess their progress and any side effects they may experience. This research is important for finding better ways to manage gastroparesis and improve the quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history of gastroparesis symptoms for at least three months, evidence of delayed stomach emptying, and a symptom score of 2.0 or higher.

    Body mass index is checked to ensure it is between 16 and 35 kg/m². Any mechanical or anatomical obstructions are ruled out through an upper gastrointestinal endoscopy or imaging technique.

  2. Step 2

    Randomization and treatment allocation

    Participants are randomly assigned to receive either Naronapride or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.

    The medication is administered orally in the form of film-coated tablets.

  3. Step 3

    Treatment phase

    The treatment lasts for 12 weeks. Participants take the assigned tablets daily as per the dosage instructions provided at the start of the trial.

    Regular monitoring of symptoms and any side effects occurs throughout this period to ensure safety and gather data on the medication's effectiveness.

  4. Step 4

    Symptom evaluation

    The primary goal is to assess changes in the average weekly total symptom score from the baseline (visit 2) to the end of treatment or withdrawal (visit 6).

    Secondary evaluations include changes in specific symptoms such as nausea, early satiety, postprandial fullness, upper abdominal pain, vomiting episodes, and bloating.

  5. Step 5

    End of treatment

    At the end of the 12-week period, a final assessment is conducted to evaluate the overall impact of the treatment on gastroparesis symptoms.

    Participants are provided with information on the study's findings and any necessary follow-up actions.

Who can join the trial?

6 criteria

  • Men and women who are between the ages of 18 and 75 years old.
  • Have had main symptoms of **idiopathic** (unknown cause) or **diabetic gastroparesis** (a condition where the stomach takes too long to empty its contents) for at least 3 months.
  • Show signs of **delayed gastric emptying**, meaning the stomach is slow to empty food.
  • Have an average weekly total symptom score of 2.0 or higher. This score measures the severity of symptoms.
  • Have a **Body Mass Index (BMI)** of 16 or more but less than 35. BMI is a number calculated from a person's weight and height.
  • Have no **mechanical or anatomical obstructions**, **stenosis** (narrowing of a passage in the body), **structural diseases**, or **gastric ulcers** (sores in the stomach lining) as confirmed by an upper gastrointestinal endoscopy or an imaging technique.

Who cannot join the trial?

10 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with a history of severe allergies to the study medication are excluded.
  • Patients with other significant stomach or intestinal diseases are not eligible.
  • People who have had major surgery on their stomach or intestines recently cannot join.
  • Participants who are currently using certain medications that affect stomach movement are excluded.
  • Individuals with uncontrolled diabetes, meaning their blood sugar levels are not stable, cannot participate.
  • Patients with severe kidney or liver problems are not eligible.
  • People with a history of alcohol or drug abuse in the past year are excluded.
  • Individuals with certain heart conditions, such as irregular heartbeats, cannot join the study.
  • Participants who have been part of another clinical trial in the last 30 days are not eligible.
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Investigated drugs

Naronapride is a medication being studied for its potential to help people with gastroparesis, a condition where the stomach takes too long to empty its contents. This trial is looking at how well Naronapride works over a 12-week period in adults who have moderate symptoms of gastroparesis, which can be caused by diabetes or other unknown reasons. The goal is to see if Naronapride can improve the signs and symptoms of this condition.

What is already known about the treatment

Naronapride – Naronapride is administered orally in tablet form. It is currently being studied in clinical trials, specifically in a phase IIb trial, to assess its effectiveness, safety, and tolerability for treating idiopathic or diabetic gastroparesis. The main therapeutic indication for Naronapride is to alleviate symptoms associated with gastroparesis, a condition that affects the normal spontaneous movement of the stomach muscles. At the molecular level, Naronapride works by enhancing gastrointestinal motility through its action as a serotonin 5-HT4 receptor agonist, which stimulates the release of neurotransmitters that increase muscle contractions in the gastrointestinal tract. It is classified pharmacologically as a prokinetic agent.

Investigated diseases

  • Idiopathic Gastroparesis

    This condition is characterized by delayed stomach emptying without an identifiable cause. Symptoms often include nausea, vomiting, feeling full quickly after eating, bloating, and abdominal pain. The progression of the disease can vary, with some individuals experiencing mild symptoms while others may have more severe and persistent issues. The exact cause of the delayed gastric emptying is unknown, which makes it challenging to predict how the condition will develop over time.

  • Diabetic Gastroparesis

    This condition occurs when diabetes affects the nerves controlling the stomach muscles, leading to delayed gastric emptying. Common symptoms include nausea, vomiting, early satiety, bloating, and abdominal discomfort. The progression of diabetic gastroparesis is often linked to the management of blood sugar levels, as poor control can exacerbate symptoms. Over time, the condition can lead to nutritional deficiencies and fluctuations in blood glucose levels due to unpredictable digestion rates.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510195-31-00Protocol codeNAT-19/GPXEstimated enrolment320 patientsSponsorDr. Falk Pharma GmbH

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).