Draft guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome

European Medicines Agency, Draft guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome, CPMP/EWP/785/97 Rev. 1, www.ema.europa.eu
Ongoing public consultation. Irritable Bowel Syndrome, Rome criteria, patient reported outcome (PRO), Health related Quality of Life (HrQoL).
Samenvatting: This guideline intends to address the EU regulatory position in the main topics of clinical development of new medicinal products in the treatment of patients with Irritable Bowel Syndrome (IBS). The main changes introduced into this guideline compared to the previous “Points to Consider on the Evaluation of Medicinal Products for the treatment of Irritable Bowel Syndrome”, refer to the following: The patient population to be selected has been changed from Rome II to Rome III criteria, and more flexibility towards possible future changes in the definition of the disease is introduced. The recommendation on primary endpoints to be used in confirmatory trials has been changed from a co-primary endpoint of global assessment and pain, to the evaluation of stool related abnormalities and pain. Moreover, dedicated chapters on special patient groups (gender, children and elderly) and on geographic region are introduced.