New hope for stomach pain? itopride study launches
NCT ID NCT07165301
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study follows 200 people with functional dyspepsia, a common stomach disorder causing fullness and pain after meals. Participants will take itopride as part of their normal care. Researchers will track symptom changes over 16 weeks to see if the drug helps in real-world settings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- itopride
- What this could lead to
- If it works, this could confirm that itopride helps ease symptoms of functional dyspepsia in Western patients, offering a new treatment option.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less reliable. Itopride's effectiveness in Western populations is still uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants are recruited in Belgium at gastroenterology outpatient clinics when their treating gastroenterologist decides to initiate itopride as part of standard clinical care for functional dyspepsia.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient diagnosed with functional dyspepsia as per physician clinical criteria * Patient must sign an informed consent document before the initiation of any study-related procedures indicating that he or she understands the purpose and procedures required for the study and is willing to participate in the study. * Patient must speak Dutch or French Exclusion Criteria: * Patient with other clinical diagnosis than functional dyspepsia that can explain their gastrointestinal symptoms. * Patient has any of the following surgical history: * Any abdominal surgery within the 3 months prior to screening; * Subject has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, cholecystectomy, or polypectomy more than 3 months earlier are allowed). * Patient has an unstable cardiac, pulmonary, renal, hepatic, metabolic, or hematologic condition. * Patient has a history of active malignancy within 3 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ). * Patient has received an investigational drug or used an investigational medical device within 30 days prior to randomization, or is currently enrolled in an investigational study. * In case of psychotropic drug use: patient NOT on stable doses of antidepressants (i.e., for the 3 months prior to pre-screening) will not be allowed to participate in the study. Habitual use of benzodiazepines is permitted. * Patient is pregnant or breastfeeding. * Patient has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UZ Leuven
Leuven, 3000, Belgium
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