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

Functional Dyspepsia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06217393
Study type Interventional
Source Abbott
Contact Suntje Sander
Phone '+49 (0) 511 6750 3254
Email suntje.sander@abbott.com
Status Recruiting
Phase Phase 3
Start date February 28, 2024
Completion date February 28, 2025
View Details
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