Which drug wins for stomach pain? new trial pits acotiamide against itopride
NCT ID NCT07449689
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether acotiamide works better than itopride for people with functional dyspepsia, a condition causing fullness, pain, or burning after meals. About 368 adults will take one of the two pills three times daily for 4 weeks and track their symptoms. The goal is to see if acotiamide improves symptoms by at least 15% more than itopride.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 368 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
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.
- Ages
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18 to 70 years
- 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 * Patients experiencing bothersome post-prandial fullness or bothersome early satiation at least three days a week. * Symptom onset must have occurred six months prior to diagnosis, and symptoms must have been present for at least the past three months. * No evidence of organic, systemic, or metabolic disease based on clinical investigations and endoscopy. * Patients with co-existing symptoms of Epigastric Pain Syndrome (EPS) are included only if the symptoms causing the most distress are meal-related. * Individuals who have already tested negative for H. pylori (separate tests will not be conducted for the study). Exclusion Criteria * Patients with an identifiable organic disease that can explain their symptoms, such as peptic ulcer, GERD, or chronic pancreatitis. * Patients with a history of gastrointestinal surgery. * History of malignancy in the past five years. * Patients having major psychiatric or depressive disorders. * Patients with a history of drug or alcohol abuse. * Patients with advanced chronic kidney disease. * Patients with uncontrolled diabetes (HbA1c \>8). * Patients with uncontrolled hypertension. * Patients diagnosed with Irritable Bowel Syndrome. * Pregnant or lactating women. * Patients who have used antibiotics, opioids, or any other medication that -affects gastrointestinal function in the past 4 weeks. * H. pylori positive patients. * Patients who cannot fill out scales or record their symptoms.
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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
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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
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More trials for these conditions
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