Clinical investigation of medicinal products for the treatment of chronic constipation - Scientific guideline

This document aims to assist applicants during the development of products for the treatment of chronic constipation and the related fields of “opioid induced constipation”. It also concerns the development of purgatives for the cleansing of the bowels in relation to procedures needing a clean bowel.

Keywords: Chronic constipation, opioid induced constipation, bowel cleansing, study design, intestinal motility, Rome III criteria

Document history - First version (current version)

Guideline on the evaluation of medicinal products for the treatment of chronic constipation (including opioid induced constipation) and for bowel cleansing

AdoptedReference Number: EMA/CHMP/336243/2013

Overview of comments received on 'Guideline on the evaluation of medicinal products for the treatment of chronic constipation (including opioid induced constipation) and for bowel cleansing'

Reference Number: EMA/CHMP/407380/2015

Draft guideline on the evaluation of medicinal products for the treatment of chronic constipation

Draft: consultation closedConsultation dates: 01/03/2014 to 31/08/2014Reference Number: EMA/CHMP/336243/2013Summary:

This guideline intends to address the European Union regulatory position in the main topics of clinical development of new medicinal products in the treatment of chronic constipation, opioid-induced constipation, and for the development of medicinal products intended for the cleansing of the bowels before medical procedures needing a “clean” bowel.

Concept paper on the need of a guideline for clinical investigation of medicinal products for the treatment of chronic constipation

Draft: consultation closedConsultation dates: 14/11/2012 to 15/02/2013Reference Number: EMA/CHMP/462198/2012Summary:

The development of medicinal products influencing gut transit and defecation is one of the oldest principles of pharmacological treatment. Numerous products have been introduced into the market even at times before drug regulation laws came into force within Europe. Nevertheless, the requirements for drug approval in this setting have never been laid down before, and the analysis of the data in support of many commonly used substances in the field have revealed that there is only insufficient evidence available to adequately support efficacy and safety of many of these substances.