Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06217393 | Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia | PHASE3 | COMPLETED | 564 | — | — | Feb 28, 2024 | Feb 28, 2025 | Apr 3, 2026 | 19 | Armenia, Malaysia +3 |
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 ...