A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia.

ABSTRACT:

Objective

To determine the efficacy of acotiamide, an acetylcholinesterase inhibitor, in patients with functional dyspepsia (FD) in a 4-week trial.

Methods

A multicentre, randomised, placebo-controlled, parallel-group, phase III trial was carried out, in which patients with FD received 100 mg of acotiamide or placebo three times a day for 4 weeks, with 4 weeks post-treatment follow-up. The primary efficacy end points were global assessment of overall treatment efficacy (OTE) and elimination rate of all three meal-related symptoms (postprandial fullness, upper abdominal bloating and early satiation), as derived from daily diaries. Secondary efficacy end points were individual symptom scores and quality of life. Adverse events were monitored.

Results

52.2% of those rece

SUBMITTER: Matsueda K 

PROVIDER: S-EPMC3345932 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature