CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 564 enrolled
Drug / intervention
Itopride Hydrochloride 150 mg extended release tablets +1 moredrug
Likely dose
Itopride Hydrochloride 150 mg extended release tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06217393
NCT06217393Phase 3Completed

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

Abbott·interventional·Posted Jan 22, 2024·Updated Apr 3, 2026

In Brief

A Phase 3 clinical trial evaluating Itopride Hydrochloride 150 mg extended release tablets and Itopride Hydrochloride 50 mg film coated tablets for Functional Dyspepsia. Completed, enrolled 564 participants across 19 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArmenia, Malaysia, Philippines, Thailand, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
202420252026
First PostedJan 22, 2024
Enrollment StartFeb 28, 2024
Primary CompletionFeb 28, 2025
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 2.4 years ago

Interventions

Itopride Hydrochloride 150 mg extended release tabletsdrug

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

Itopride Hydrochloride 50 mg film coated tabletsdrug

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