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 ...
Itopride is used for the treatment of functional dyspepsia, a gastrointestinal condition involving symptoms such as upper abdominal discomfort, early satiety, and postprandial fullness. It is being developed by Abbott Laboratories as a small molecule therapy for this indication and has been studied in a Phase 3 clinical trial in patients with functional dyspepsia.
Itopride targets dopamine D2 receptors (DRD2) and acetylcholinesterase (ACHE). It acts as an antagonist at DRD2 and inhibits ACHE, which together support its prokinetic and gastroprokinetic activity in the gastrointestinal tract. This dual mechanism is intended to improve gastric emptying and motility in patients with functional dyspepsia.
Itopride is being developed by Abbott Laboratories, which trades on the New York Stock Exchange under the ticker symbol ABT. Abbott is a global healthcare company with a broad portfolio that includes pharmaceutical products. The company is advancing itopride as a treatment for functional dyspepsia.
Itopride is in Phase 3 clinical development for functional dyspepsia. It is an investigational small molecule and has not been approved by the FDA for this indication. The Phase 3 trial has been completed, and the drug remains under clinical evaluation by Abbott Laboratories.
Itopride has been studied in a completed Phase 3 trial, NCT06217393, titled "Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia." The trial enrolled 564 patients across Armenia, Malaysia, the Philippines, Thailand, and Vietnam. It was randomized and active-controlled.