Urgency as an Endpoint in Irritable Bowel Syndrome.

ABSTRACT:

Background

The choice of endpoints is crucial for proper evaluation of agents in clinical trials of irritable bowel syndrome (IBS). In a recently published draft guidance for IBS from the United States Food and Drug Administration (FDA), urgency was not considered an appropriate primary endpoint. The FDA's position is that it is not clear how patients with diarrhea-predominant IBS (D-IBS) "define or describe urgency". The aims of this study were to evaluate the association of urgency with stool frequency and consistency in patients with D-IBS and to describe results from patient interviews on their understanding of the term urgency.

Methods

A retrospective analysis of clinical trial data in patients with D-IBS was conducted. Analyses focused on the relationship of urgency to

SUBMITTER: Mangel AW 

PROVIDER: S-EPMC5139794 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature