Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia

Randomized Multicentre Open-label Study to Investigate the Non-inferiority of Itopride Hydrochloride 150mg Once Daily Versus Itopride Hydrochloride 50 mg Thrice Daily in Subjects With Functional (Non-ulcer) Dyspepsia or Chronic Gastritis

The study is conducted in patients with functional dyspepsia or chronic gastritis. The purpose of this study is to:

• assess whether the dose of Itopride Hydrochloride 150 mg extended release tablets, taken once daily has a similar effect on gastrointestinal symptoms caused by gastric dysmotility and delayed gastric emptying, like bloating sensation, early satiety, postprandial fullness, upper abdominal pain or discomfort, anorexia, heartburn, nausea and vomiting in functional (non-ulcer) dyspepsia or chronic gastritis, as Itopride Hydrochloride 50 mg film coated tablets administered thrice a day.
• investigate assessment of the treatment provided to each participant.
• monitor safety and tolerability of Itopride Hydrochloride 150 mg extended release tablets, taken once daily before one of the main meals (preferably same meal throughout the treatment) and Itopride Hydrochloride 50 mg film coated tablets thrice daily before meals.

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Drug: Itopride Hydrochloride 150 mg extended release tablets; Drug: Itopride Hydrochloride 50 mg film coated tablets

Detailed Description

This is a muti-national study, in subjects with functional dyspepsia. The study will screen approximately 700 subjects and include 564 subjects (282 subjects in both arms Test and Active control arm) and the treatment will be given as follows.

• Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before any of the main meals (preferably same meal throughout the treatment) OR
• Active Control group - Itopride Hydrochloride 50 mg film coated tablets thrice daily before meals Total study participation will include screening for two weeks, treatment duration of eight weeks and follow-up for one week after the end of treatment.

• Study Type: Interventional
• Enrollment (Actual): 564
• Phase: Phase 3

Contacts and Locations

Study Locations

• Armenia
  • Yerevan, Armenia
    • "Grigor Narekatsi" MC, CJSC
  • Yerevan, Armenia
    • "Hera Med" LLC ("Medicus" Medical Center)
  • Yerevan, Armenia
    • "Institute of Surgery Mickaelyan" CJSC
  • Yerevan, Armenia
    • Polyclinic N 12 Health State, CJSC
• Malaysia
  • Alor Star, Malaysia
    • Hospital Sultanah Bahiyah
  • Kota Kinabalu, Malaysia
    • Queen Elizabeth Hospital
  • Kuala Lumpur, Malaysia
    • Pantai Hospital Kuala Lumpur
  • Petaling Jaya, Malaysia
    • UMMC
• Philippines
  • Cebu City, Philippines, 6000
    • Cebu Doctors University Hospital
  • Davao City, Philippines, 8000
    • Davao Doctors Hospital
  • Manila, Philippines
    • Health Cube Medical Clinics
  • Pampanga, Philippines, 2000
    • GreenCity Medical Center
• Thailand
  • Bangkok, Thailand, 10400
    • Phramongkulklao Hospital
  • Bangkok, Thailand, 13300
    • King Chulalongkorn Memorial
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
• Vietnam
  • Hanoi, Vietnam
    • Bach Mai hospital
  • Hanoi, Vietnam
    • 103 Military Hospital
  • Ho Chi Minh City, Vietnam, 70000
    • Nguyen Tri Phuong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals; Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)	Drug: Itopride Hydrochloride 150 mg extended release tablets; The intervention in the study is in form of test and active control groups- see details below • Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment) • Active Control group - Itopride Hydrochloride 50 mg film coated tablets 3 times daily before meals
Active Comparator: Active Control group - Itopride Hydrochloride 50 mg film	Drug: Itopride Hydrochloride 50 mg film coated tablets; The intervention in the study is in form of test and active control groups- see details below • Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment) • Active Control group - Itopride Hydrochloride 50 mg film coated tablets 3 times daily before meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Overall Severity of Functional Dyspepsia Between Baseline and Week 8, as Measured by the LDQ Severity Score	Change in the overall severity of functional dyspepsia between baseline and week 8, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score consisting of 15 questions, where questions 1-8 are used to measure the severity, on a scale of 0 to 5 (0= absence, 1= very mild, 5=very severe). End Result: Maximum severity score is 40, symptom free=0, very mild =1-4, mild=5-8, moderate=9-15, severe is 16-40	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Overall Severity of Functional Dyspepsia Between Baseline and Week 4, as Measured by the LDQ Severity Score	Change in the overall severity of functional dyspepsia between baseline and week 4, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score. Change in the overall severity of functional dyspepsia between baseline and week 8, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score consisting of 15 questions, where questions 1-8 are used to measure the severity, on a scale of 0 to 5 (0= absence, 1= very mild, 5=very severe). End Result: Maximum severity score is 40, symptom free=0, very mild =1-4, mild=5-8, moderate=9-15, severe is 16-40.	4 weeks
Disease Specific Quality of Life (Nepean Dyspepsia Index NDI) Assessed at Baseline and Week 8 in Terms of Change in % of Functional Ability.	To assess quality of life for the two treatment arms using Disease Specific Quality of Life (Short Form - Nepean Dyspepsia Index SF-NDI) at baseline and end of treatment. The SF-NDI measures dyspepsia's impact on quality of life, with scores ranging from 10-50 (higher = worse). It includes five subscales-tension/anxiety, daily activities, eating/drinking, knowledge/control, and work/study-each with two questions rated on a 5-point Likert scale (1 = not at all, 5 = extremely). Step-1: sum of scores, step-2: converted to %disability, Step-3: convert to %functional ability (100-%disability). Higher score represents higher Quality of Life and lower scores lower Quality of Life.	8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Sensation of Bloating) After 4 Weeks of Treatment.	Change from baseline of NRS 11 score for symptoms (sensation of bloating, early satiety, postprandial fullness, upper abdominal pain or discomfort (epigastric pain, epigastric burning), anorexia (loss of appetite), heartburn, nausea and vomiting) after 4 and 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Sensation of Bloating) After 8 Weeks of Treatment.	Participants assigned to Itopride Hydrochloride 150 mg extended release tablets group administered one tablet a day for 8 weeks. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Early Satiety) After 4 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Early Satiety) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Early Satiety) After 8 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Early Satiety) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Postprandial Fullness) After 4 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Postprandial Fullness) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Postprandial Fullness) After 8 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (postprandial Fullness) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Upper Abdominal Pain or Discomfort) After 4 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Upper Abdominal Pain or Discomfort) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Upper Abdominal Pain or Discomfort) After 8 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Upper Abdominal Pain or Discomfort) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Anorexia (Loss of Apetite)) After 4 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Anorexia (Loss of Apetite)) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Anorexia (Loss of Apetite)) After 8 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Anorexia (Loss of Apetite)) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Heartburn) After 4 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Heartburn) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Heartburn) After 8 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Heartburn) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Nausea) After 4 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Nausea) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Nausea) After 8 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Nausea) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Vomiting) After 4 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Vomiting) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Vomiting) After 8 Weeks of Treatment.	We have assessed the change from baseline of NRS 11 score for symptoms (Vomiting) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Acceptance by Subjects Using 5-point Likert Scale at the End of the Treatment	Treatment acceptance and ease of use assessed by subjects using 5-point Likert scale (1. Not at all satisfied, 2. Slightly satisfied, 3. Neutral, 4. Very satisfied, 5. Extremely satisfied.)	8 weeks
Evaluation of Safety and Tolerability in Both Treatment Arms	Evaluation of the safety and tolerability of the two treatments by assessing the following safety endpoints: Treatment emergent adverse events (TEAEs) as detected by physical examination, laboratory assessments and vital signs. For each unique treatment, treatment emergent AEs will be summarized per primary standard of care, Highest Level Term by primary Standard of care and per preferred term by highest level term and primary standard of care.	8 weeks

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Suntje Sander, Abbott Laboratories GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: November 24, 2023
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Functional Dyspepsia; heartburn; Bloating; nausea and vomiting; postprandial fullness; anorexia; Early satiety; gastrointestinal symptoms; chronic gastritis; gastric dysmotility; upper abdominal pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Abdominal Pain; Nausea; Vomiting; Heartburn; Anorexia
• Other Study ID Numbers: ITOP-322-0216

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No