Clinical investigation of medicinal products for the treatment of chronic constipation

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/336243/2013
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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