Could one pill a day replace three for stomach upset?
NCT ID NCT06217393
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested if taking itopride once daily works as well as taking it three times a day for people with ongoing stomach discomfort (functional dyspepsia). Over 500 adults participated, and researchers measured symptom changes over 8 weeks. The goal was to see if a simpler dosing schedule could provide similar relief.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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564 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Feb 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 99 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: 1. Adult male and/or non-pregnant non-lactating female subjects aged above 18 years. 2. Subjects provided written informed consent and are willing to participate in the study. 3. Subjects with functional (non-ulcer) dyspepsia according to Rome IV criteria including postprandial distress syndrome (PDS) and with or without EPS (epigastric pain syndrome) with one or more of the following: * bothersome postprandial fullness, * bothersome early satiation * bothersome epigastric pain, * bothersome epigastric burning for at least 12 weeks in the preceding 6 months 4. No evidence of organic, systemic, metabolic or structural disease likely to explain symptoms - Subjects who have to undergone physical examination and lab tests (including white-cell and red-cell counts, measurement of fasting blood sugar and liver-function tests), abdominal ultrasonography, and upper GI endoscopy\* in order to rule out structural cause for symptoms of FD. \*history of upper GI endoscopy within 6 months prior to enrolment or at screening. 5. Baseline severity of at least moderate symptoms on LDQ (total score ≥ 9) at screening. 6. H. pylori negative documented test report within 3 months prior to enrolment or during screening. Exclusion Criteria: 1. Known hypersensitivity to Itopride or any component of the formulation and to any other related drug. 2. Subject with history or presence of clinically relevant evidence of cardiovascular, neurological, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/ connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant disease as revealed by medical history requiring treatment which at investigator's discretion might interfere with the study. 3. Subjects who cannot be treated with Itopride in line with the prescribing information. 4. Subjects scheduled for surgery during the study. 5. Subjects with a history of difficulty in swallowing. 6. Subject requiring concomitant treatment with anticholinergic drugs, drugs with narrow therapeutic index, sustained release or enteric-coated formulations. 7. Subjects taking Acid release inhibitors (e.g. histamine-2-receptor \[H2\]- antagonists, proton pump inhibitors \[PPI\], or potassium-competitive acid blockers), antacids (e.g. aluminium- or magnesium hydroxide, sodium bicarbonate), gastric mucosa protectors (e.g. sucralfate, rebamipide). 8. Subject with history of unusual bleeding and family history for bleeding disorders. 9. Subjects with only reflux-related symptoms or who have predominantly reflux-related symptoms. 10. Subjects with esophagitis, Barrett's esophagus, erosions or peptic ulcer disease within one year prior to the study or Zollinger-Ellison Syndrome. 11. Dyspepsia that is exclusively relieved by defecation or associated with a change in stool frequency or stool form to exclude IBS. 12. Clinically significant ECG abnormalities. 13. Subjects treated with Itopride or any other gastroprokinetic within 4 weeks prior to screening. 14. Subjects who took non-steroidal anti-inflammatory drugs for more than 2 weeks prior to screening 15. Subjects with refractory FD1 (defined as FD presenting symptoms continuing for at least 6 months, unresponsive to at least two medical treatments such as PPIs, prokinetics, or H. pylori eradication) as per investigator's discretion 16. History of or known inflammatory bowel disease (IBD) or coeliac disease. 17. History of or known severe hepatic, renal, pancreatic, cardiac, metabolic, hematological or malignant disease or trimethylaminuria. 18. Subjects with changed smoking status within the last three months. 19. History of or known GI malignancy or ulcers associated to malignancy or any alarm features for GI malignancy, e.g. GI bleeding. 20. Subjects who do not meet the criteria stated in concomitant medication section. 21. Subjects with history of severe depression, anxiety or other psychological disorders. 22. Females with child-bearing potential must agree to use an acceptable method of contraception during the study. 23. Subjects in whom an increase in gastrointestinal motility could be harmful, e.g., (history of) gastrointestinal hemorrhage, mechanical obstruction or perforation. 24. Specific food intolerance which is relieved by diet modifications (e.g. lactose intolerance, celiac disease). 25. Subjects with confirmed IBS as per Rome IV criteria. 26. Current alcohol or drug abuse. 27. History of abdominal surgery except appendectomy, cholecystectomy or hysterectomy, tubal ligations, bladder slings or vasectomies. 28. Hepatic cirrhosis or abnormal liver laboratory findings (defined as \>3xULN of ALT or AST). 29. Subjects under hemodialysis therapy or having advanced chronic kidney disease (defined as eGFR \<60 mL/min). 30. History of or known congestive heart failure NYHA class III and IV, or any other uncontrolled chronic diseases, such as: uncontrolled hypertension (systolic/diastolic blood pressure ≥160/100 mmHg); uncontrolled diabetes (HbA1c \>8%). 31. Subjects currently being known to be afflicted by serious infection(s), or any known severe illness(es) which are judged by the investigator could interfere with subjects' safety and/or study evaluation.
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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.
Contacts and locations
Locations
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"Grigor Narekatsi" MC, CJSC
Yerevan, Armenia
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"Hera Med" LLC ("Medicus" Medical Center)
Yerevan, Armenia
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"Institute of Surgery Mickaelyan" CJSC
Yerevan, Armenia
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103 Military Hospital
Hanoi, Vietnam
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Bach Mai Hospital
Hanoi, Vietnam
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Cebu Doctors University Hospital
Cebu City, 6000, Philippines
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Davao Doctors Hospital
Davao City, 8000, Philippines
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GreenCity Medical Center
Pampanga, 2000, Philippines
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Health Cube Medical Clinics
Manila, Philippines
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Hospital Sultanah Bahiyah
Alor Star, Malaysia
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King Chulalongkorn Memorial
Bangkok, 13300, Thailand
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Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
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Nguyen Tri Phuong Hospital
Ho Chi Minh City, 70000, Vietnam
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Pantai Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
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Phramongkulklao Hospital
Bangkok, 10400, Thailand
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Polyclinic N 12 Health State, CJSC
Yerevan, Armenia
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Queen Elizabeth Hospital
Kota Kinabalu, Malaysia
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Srinagarind Hospital
Khon Kaen, 40002, Thailand
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UMMC
Petaling Jaya, Malaysia
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