Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Itopride film coated · 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 ...
Itopride film coated is used for functional dyspepsia, a gastrointestinal condition. It is a small molecule drug being developed by Abbott Laboratories and is currently in Phase 3 clinical development. The drug is being studied in patients with functional dyspepsia to evaluate its efficacy and safety.
Itopride film coated is a small molecule drug being developed for functional dyspepsia. The specific molecular target of Itopride film coated is not disclosed in the available information. The drug is being studied in Phase 3 clinical trials to assess its effects in patients with functional dyspepsia.
Itopride film coated is being developed by Abbott Laboratories, a company listed on the stock exchange under the ticker ABT. The drug is currently in Phase 3 clinical development for the treatment of functional dyspepsia, a gastrointestinal disorder.
Itopride film coated is in Phase 3 clinical development. It is an investigational drug being studied for functional dyspepsia. The drug has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients.
Itopride film coated is being studied in a Phase 3 clinical trial with the identifier NCT06217393. This trial, titled "Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia," has been completed and enrolled 564 participants. The trial was conducted in Armenia, Malaysia, Philippines, Thailand, and Vietnam.
Itopride film coated is a formulation of the drug itopride. The clinical trial NCT06217393 compares two dosing regimens of itopride: 150 mg once a day versus 50 mg three times a day, in patients with functional dyspepsia. The film-coated formulation is being studied for this indication.