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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Centre Hospitalier Universitaire De Lille Lille France
University Hospital Maastricht Maastricht The Netherlands
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Amicare Sp. z o.o. S.K. Lodz Poland
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Klinikum Region Hannover GmbH Hanover Germany
Universitaetsklinikum Brandenburg an der Havel GmbH Brandenburg An Der Havel Germany
Hospital Edouard Herriot Lyon France
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o. Malbork Poland
Vita Longa Sp. z o.o. Katowice Poland
Ip Clinic Sp. z o.o. Lodz Poland
Szpital Miejski Sw. Jana Pawla II W Elblagu Elblag Poland
Eugastro GmbH Leipzig Germany
Endoskopia Sp. z o.o. Sopot Poland
Centrum Medyczne Clw-Med Aneta Cichomska I Joanna Luka-Wendrowska Sp. j. Grudziadz Poland
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gGmbH Bamberg Germany
Azienda Ospedaliera di Padova Padua Italy
Digestive Diseases Centre Gastro SIA Riga Latvia
Universita’ Di Pisa Pisa Italy
Kepler Universitaetsklinikum GmbH Linz Austria
Liepajas Regionala Slimnica SIA Liepaja Latvia
Hopital Beaujon Clichy France
Vrije Universiteit Brussel Jette Belgium
Allmedica Badania Kliniczne Sp. z o.o. Nowy Targ Poland
Centermed Krakow Sp. z o.o. Cracow Poland
Clhhuiaqg Uerfiqmbdtafjd Srjvgnehv Woluwe-Saint-Lambert Belgium
Rujgksvrm Zsdzbwltwz Slnctfcsh Arnhem The Netherlands
Uoekbwdfhrggmuejmcwko Adlazcao Augsburg Germany
Cpbkelp Mjtayxde Lsyzwmk Jhefbg Łlvs Chojnice Poland
Tdbpgkn Szb z oyme Poznan Poland
Ngotbnavkwea Zmezvo Oaqylq Znyngezhmx Toevb Znrftlk Ep Stt z obhb Elblag Poland
Ncwh Vqoj Dgpxsuhtz Mayllcmfjn Bazcasjw Bialystok Poland
Eewkixobvkzw W Btqfr D Mbomoydnpc P Mvqxbgdvcy J Ssqlnbv sroj Opole Poland
Igfzdzxcnsmoav Kqhdkyweijl Hclcgml Hamburg Germany
Scfnkrtw Reihckz Cdxgmcbv ip Dqpp Rwleryjd axp Dkzcyrdwgzg Gtkc Erfurt Germany
Lqmeirg Kxylrzts &vfyfbh Kwbwpleacst Vdwwujzscx Vilsbiburg Germany
Emahfkvttmhckjep Buopky Bhnumcxmjxb Berlin Germany
Cemt Do Nzdwh Vandoeuvre Les Nancy France
Uyytckpdto Oc Aczhpfq Edegem Belgium
Uhyonaffazavcextfxkd Reuwiyhuvuyjbzcuke Neuruppin Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
15.07.2022
Belgium Belgium
Not recruiting
15.07.2022
France France
Not recruiting
15.07.2022
Germany Germany
Not recruiting
15.07.2022
Italy Italy
Not recruiting
15.07.2022
Latvia Latvia
Not recruiting
15.07.2022
Poland Poland
Not recruiting
15.07.2022
The Netherlands The Netherlands
Not recruiting
15.07.2022

Trial locations

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.

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 ID:
2023-510195-31-00
Protocol code:
NAT-19/GPX
NCT ID:
NCT05621811
Trial Phase:
Therapeutic exploratory (Phase II)

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