A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia
Completed
Astellas Pharma Inc
Phase 3
To examine the safety and efficacy of Z-338 (YM443) after long-term administration in
patients with functional dyspepsia, and also to examine the pattern of long-term
administration.
Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers
Completed
Universitaire Ziekenhuizen Leuven
N/A
Introduction. Functional dyspepsia (FD) is a common chronic gastrointestinal disorder with a
high socio-economic impact. Acotiamide, a new prokinetic agent, was shown to be efficacious
in the treatment of FD, especially in the postprandial distress syndrome subgroup. To date,
the exact mechanism of action of acotiamide is incompletely elucidated.
The aim of this study was to examine the effect of acotiamide on gastric motility, gastric
emptying rate and gastrointestinal symptom perception in healthy participants in a
randomized, placebo-controlled, cross-over study design. Participants were treated with
acotiamide (100 mg t.i.d.) and placebo for 3 weeks, separated by a one-week wash-out period.
At the end of each treatment period, gastric emptying and motility were assessed on two
consecutive study days. During gastric motility assessment, epigastric symptom scores were
collected at multiple time points.
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