Clinical investigation of medicinal products for the treatment of chronic constipation

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/336243/2013
Published14/09/2015
Effective from01/01/2016
KeywordsChronic constipation, opioid induced constipation, bowel cleansing, study design, intestinal motility, Rome III criteria
DescriptionThis 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.


Document history

First version

Current version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

PDF iconConcept paper

In operation: 01/01/2016–present

Published: 14/09/2015

Published: 28/02/2014

Published: 14/11/2012


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