Functional Dyspepsia Clinical Trial
Official title:
Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
Pathogenesis of functional dyspepsia is poorly understood. Gastrointestinal motor
abnormalities, Helicobacter pylori infection, impaired gastric accommodation to a meal,
hypersensitivity of the afferent nerves of the gut, psychological disturbances and central
nervous system dysfunction have been proposed.
Pharmacological treatments for patients with functional dyspepsia remain unsatisfactory.
Only small benefits relative to placebo have been found with histamine H2 receptor
antagonists, proton pump inhibitor and Helicobacter pylori eradication.
Itopride is a dopamine antagonist with acetylcholinesterase inhibitory actions. This agent
is currently indicated for patients with various upper GI symptoms.
This study is aimed to evaluate the effect of Itopride on gastric emptying(by 13-C Octanoic
acid breath Test), accommodation (by Gastric Scintigraphy SPECT and slow nutrient drinking
test)and symptoms in FD patients
phase3 clinical trial ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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