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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
564
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
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
"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
...and 9 more locations
To assess the comparable efficacy of Itopride Hydrochloride 150 mg extended release tablet (administered once daily) and Itopride Hydrochloride 50 mg film coated tablets (administered TID) after 8 weeks' treatment
Change in the overall severity of functional dyspepsia between baseline and week 8, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score
Time frame: 8 weeks
To assess the comparable efficacy of Itopride Hydrochloride 150mg extended release tablet (administered once daily) and Itopride Hydrochloride 50 mg film coated tablets (administered TID) after 4 weeks treatment.
Change in the overall severity of functional dyspepsia between baseline and week 4, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score
Time frame: 4 weeks
To assess quality of life for the two treatment arms using Disease Specific Quality of Life (Short Form - Nepean Dyspepsia Index SF-NDI) at baseline and end of treatment
Disease Specific Quality of Life (Nepean Dyspepsia Index NDI) assessed at baseline and week 8
Time frame: 8 weeks
Assess the symptomatology (sensation of bloating, early satiety, abdominal pain or discomfort, epigastric pain, epigastric burning, anorexia, heartburn, nausea and vomiting) of the disease in both treatment arms after 4 and 8 weeks of treatment.
Change from baseline of NRS 11 score for symptoms (sensation of bloating, early satiety, postprandial fullness, upper abdominal pain or discomfort (epigastric pain, epigastric burning), anorexia (loss of appetite), heartburn, nausea and vomiting) after 4 and 8 weeks of treatment
Time frame: 8 weeks
Change in the overall severity of functional dyspepsia between baseline and week 4, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score (range 0-40), where 0 is symptom free and 40 is severe dyspepsia
Responder analysis for adequate/satisfactory relief as assessed by LDQ and/or NRS 11
Time frame: 8 weeks
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