Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Itopride · 1 trial · 1 indication
Change in the overall severity of functional dyspepsia between baseline and week 8, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score consisting of 15 questions, where questions 1-8 are used to measure the severity, on a scale of 0 to 5 (0= absence, 1= very mild, 5=very severe). End Result: Maximum severity score is 40, symptom free=0, very mild =1-4, mild=5-8, moderate=9-15, severe is 16-40
| Arm | Type | Description |
|---|---|---|
| Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals | EXPERIMENTAL | 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 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Itopride Hydrochloride 150 mg extended release tablets | DRUG | 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 tablets | DRUG | 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 |
Inclusion Criteria: 1. Adult male and/or non-pregnant non-lactating female subjects aged above 18 years. 2. Subjects provided written informed consent and are willing to participate in the study. 3. Subjects with functional (non-ulcer) dyspepsia according to Rome IV criteria including postprandial ...