Phase III, Long-term, Open-label Safety Study of Z-338

Summary

The primary objective of this study is to evaluate the long-term safety of 100 mg Z-338 TID in European subjects with FD.

Timeline

Start

2014-03

Primary completion

2016-11

Completion

2017-04

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper however a controlled trial is required to confirm this hypothetic efficacy of acotiamide. PMID 29315999 ↗

Publications

• Tack J, Pokrotnieks J, Urbonas G, Banciu C, Yakusevich V, Bunganic I, Tornblom H, Kleban Y, Eavis P, Tsuchikawa M, Miyagawa T. Long-term safety and efficacy of acotiamide in functional dyspepsia (postprandial distress syndrome)-results from the European phase 3 open-label safety trial. Neurogastroenterol Motil. 2018 Jun;30(6):e13284. doi: 10.1111/nmo.13284. Epub 2018 Jan 8.

Drugs

Indications