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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
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.
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.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
"Grigor Narekatsi" MC, CJSC
Yerevan, Armenia
"Hera Med" LLC ("Medicus" Medical Center)
Yerevan, Armenia
"Institute of Surgery Mickaelyan" CJSC
Yerevan, Armenia
Polyclinic N 12 Health State, CJSC
Yerevan, Armenia
Hospital Sultanah Bahiyah
Alor Star, Malaysia
Queen Elizabeth Hospital
Kota Kinabalu, Malaysia
Pantai Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
UMMC
Petaling Jaya, Malaysia
Cebu Doctors University Hospital
Cebu City, Philippines
Davao Doctors Hospital
Davao City, Philippines
Start Date
February 28, 2024
Primary Completion Date
February 28, 2025
Completion Date
February 28, 2025
Last Updated
January 29, 2025
564
ACTUAL participants
Itopride Hydrochloride 150 mg extended release tablets
DRUG
Itopride Hydrochloride 50 mg film coated tablets
DRUG
Lead Sponsor
Abbott
NCT07182890
NCT07196735
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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