Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia
CompletedPhase 3NCT06217393
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- 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
- Conditions
- Functional Dyspepsia
- Interventions
- Drug: Itopride Hydrochloride 150 mg extended release tablets
- Drug: Itopride Hydrochloride 50 mg film coated tablets
- Sponsor
- Abbott
- Start date
- 2024-02-28
- Primary completion
- 2025-02-28
- Sex
- All
- Age range
- from 18 Years to 99 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Armenia, Malaysia, Philippines, Thailand, Vietnam
- Total sites listed
- 19
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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. s…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06217393