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

Inclusion Criteria

• Adult male and/or non-pregnant non-lactating female subjects aged above 18 years.
• Subjects provided written informed consent and are willing to participate in the study.
• 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
• 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.

• Baseline severity of at least moderate symptoms on LDQ (total score ≥ 9) at screening.
• H. pylori negative documented test report within 3 months prior to enrolment or during screening.

Exclusion Criteria

• Known hypersensitivity to Itopride or any component of the formulation and to any other related drug.
• 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.
• Subjects who cannot be treated with Itopride in line with the prescribing information.
• Subjects scheduled for surgery during the study.
• Subjects with a history of difficulty in swallowing.
• Subject requiring concomitant treatment with anticholinergic drugs, drugs with narrow therapeutic index, sustained release or enteric-coated formulations.
• 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).
• Subject with history of unusual bleeding and family history for bleeding disorders.
• Subjects with only reflux-related symptoms or who have predominantly reflux-related symptoms.
• Subjects with esophagitis, Barrett's esophagus, erosions or peptic ulcer disease within one year prior to the study or Zollinger-Ellison Syndrome.
• Dyspepsia that is exclusively relieved by defecation or associated with a change in stool frequency or stool form to exclude IBS.
• Clinically significant ECG abnormalities.
• Subjects treated with Itopride or any other gastroprokinetic within 4 weeks prior to screening.
• Subjects who took non-steroidal anti-inflammatory drugs for more than 2 weeks prior to screening
• 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
• History of or known inflammatory bowel disease (IBD) or coeliac disease.
• History of or known severe hepatic, renal, pancreatic, cardiac, metabolic, hematological or malignant disease or trimethylaminuria.
• Subjects with changed smoking status within the last three months.
• History of or known GI malignancy or ulcers associated to malignancy or any alarm features for GI malignancy, e.g. GI bleeding.
• Subjects who do not meet the criteria stated in concomitant medication section.
• Subjects with history