To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia

Summary

The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms.

Timeline

Start

2008-09

Primary completion

2010-06

Completion

2010-08

Outcome

Met primary endpoint

paper 52.2% of those receiving acotiamide and 34.8% in the placebo group (p<0.001) were classified as responders according to a global assessment of OTE. PMID 22157329 ↗

paper The elimination rate for all three meal-related symptoms was 15.3% among patients receiving acotiamide compared with 9.0% in the placebo group (p=0.004). PMID 22157329 ↗

release “In both of two primary endpoints employed in the present study, acotiamide was statistically significantly effective when compared to placebo.” zeria.co.jp ↗

Publications

• Matsueda K, Hongo M, Tack J, Saito Y, Kato H. A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia. Gut. 2012 Jun;61(6):821-8. doi: 10.1136/gutjnl-2011-301454. Epub 2011 Dec 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acotiamide	Small molecule	100 mg	Oral

Indications