Comparing Acotiamide and Itopride for the Management of Indigestion (NCT07449689) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Comparing Acotiamide and Itopride for the Management of Indigestion
368 participantsStarted 2026-04
Plain-language summary
This study is a randomized, double-blinded trial that will compare the effectiveness of two medications, acotiamide and itopride, in treating Functional Dyspepsia. Functional Dyspepsia causes uncomfortable symptoms arising from the gastro-duodenal region, such as fullness after meals, early satiation, stomach pain, and burning.
The primary aim of this trial is to determine whether acotiamide is superior to itopride-specifically by a margin of 15%-at improving these meal-related digestive symptoms.
Participants will be involved in the study for a total of 5 weeks. The study begins with a 7-day baseline period where participants will track their symptoms daily.
Following the baseline period, participants will be randomly assigned to receive either 100mg of acotiamide three times a day or 50mg of itopride three times a day.
The treatment phase will last for 4 weeks, during which participants will take the medication before meals on an empty stomach.
Participants will continue to track their symptoms daily and will complete questionnaires about their overall treatment effect and quality of life at follow-up visits.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.