Randomised clinical trial: minesapride vs placebo for irritable bowel syndrome with predominant constipation.

ABSTRACT:

Background

Agonists of 5-hydroxytryptamine 4 receptor are potential agents for irritable bowel syndrome with predominant constipation (IBS-C). However, only tegaserod has been approved for a very limited population in the US.

Aim

To evaluate the efficacy and safety of minesapride in patients with Rome IV defined IBS-C.

Methods

A double-blind, placebo-controlled, dose-finding study was performed. Overall, 411 patients were randomised to receive minesapride at 10, 20 or 40 mg/d, or placebo for 12 weeks. The primary endpoint was Food and Drug Administration (FDA) composite endpoint (responder: a patient who reported an increase in one or more complete spontaneous bowel movements from baseline and improvement of ≥30% from baseline in weekly average of worst abdominal pain

SUBMITTER: Hamatani T 

PROVIDER: S-EPMC7383621 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature