A double-blind, randomised, placebo controlled crossover study on the effects of 100mg, three times daily, Z-338 on the symptomatic response to a nutrient challenge and gasteric nutrient distribution and emptying in subjects with and without functional dyspepsia.

INTERVENTION: Recent studies have demonstrated that various pharmacologic treatments including proton pump inhibitors (PPI) and prokinetics and psychological treatments improve the symptoms in subjects with functional dyspepsia. The mode of action of gastroprokinetic drugs is via various receptor mechanisms, which include action at motlin receptors, serotonin receptors, dopamine receptors and/or acetylcholinesterase.The effects of treatment with the study drug Z‐338 yielded significant improvement of symptoms in functional dyspepsia in a well controlled study in Japan. The aim of this study, therefore, is to assess in healthy controls and subjects with functional dyspepsia the effects of the study drug Z‐338 on the type and severity of symptoms during standardized nutrient challenge, the gastric nutrient distribution and gastric emptying of a standardized nutrient challenge and the association of the prior mentioned points with manifestations of symptoms and symptom pattern. CONDITION: Functional dyspepsia PRIMARY OUTCOME: To assess the improvement of meal related symptoms in healthy controls and subjects with functional dyspepsia during treatment with Z‐338. SECONDARY OUTCOME: Changes of gastric emptying and the link of regional gastric nutrient distribution/gastric emptying and improvement of meal related symptoms referred to the upper stomach occurs (i.e. pain, nausea, fullness and discomfort) will be analyzed. The influence of the treatment on the regional nutrient distribution (%) of ingested test meal in the proximal and distal stomach. INCLUSION CRITERIA: (Subjects with no history of functional dyspepsia):1) Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality (e.g. no need for further clinical testing)Inclusion criteria (Subjects with functional dyspepsia):1) Diagnosis of functional dyspepsia according to Rome II criteria and three or more moderate symptoms of Gastrointestinal Symptom Score.