NCT06217393

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 564 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2024-02-28
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2024-01-22
• Last updated: 2026-04-03
• Results posted: 2026-04-03

Locations

19 sites across 5 countries: Armenia, Malaysia, Philippines, Thailand, Vietnam