Comparing Acotiamide and Itopride for the Management of Indigestion

Summary

This study is a randomized, double-blinded trial that will compare the effectiveness of two medications, acotiamide and itopride, in treating Functional Dyspepsia. Functional Dyspepsia causes uncomfortable symptoms arising from the gastro-duodenal region, such as fullness after meals, early satiation, stomach pain, and burning. The primary aim of this trial is to determine whether acotiamide is superior to itopride-specifically by a margin of 15%-at improving these meal-related digestive symptoms. Participants will be involved in the study for a total of 5 weeks. The study begins with a 7-day baseline period where participants will track their symptoms daily. Following the baseline period, participants will be randomly assigned to receive either 100mg of acotiamide three times a day or 50mg of itopride three times a day. The treatment phase will last for 4 weeks, during which participants will take the medication before meals on an empty stomach. Participants will continue to track their symptoms daily and will complete questionnaires about their overall treatment effect and quality of life at follow-up visits.

Timeline

Start

2026-04

Primary completion

2026-12

Completion

2027-05

Publications

• Background Huang X, Lv B, Zhang S, Fan YH, Meng LN. Itopride therapy for functional dyspepsia: a meta-analysis. World J Gastroenterol. 2012 Dec 28;18(48):7371-7. doi: 10.3748/wjg.v18.i48.7371.
• Background Tack J, Masclee A, Heading R, Berstad A, Piessevaux H, Popiela T, Vandenberghe A, Kato H. A dose-ranging, placebo-controlled, pilot trial of Acotiamide in patients with functional dyspepsia. Neurogastroenterol Motil. 2009 Mar;21(3):272-80. doi: 10.1111/j.1365-2982.2009.01261.x.
• Background Xiao M, Ying J, Zhao Y, Zhao Y, Liu Y, Lu F. Developing a Scale for the Evaluation of People With Post-prandial Distress Syndrome. Front Public Health. 2021 Jun 29;9:695809. doi: 10.3389/fpubh.2021.695809. eCollection 2021.
• Background Ang D, Talley NJ, Simren M, Janssen P, Boeckxstaens G, Tack J. Review article: endpoints used in functional dyspepsia drug therapy trials. Aliment Pharmacol Ther. 2011 Mar;33(6):634-49. doi: 10.1111/j.1365-2036.2010.04566.x. Epub 2011 Jan 12.

Drugs

Indications