Trial Information

Official Title: A Randomized, Double-blind, Cross-over Trial in Patients With Irritable Bowel Syndrome Investigating the Efficacy and Safety of PPC-5650 on Sensation and Pain During Standardized Stimulation of the Rectosigmoid

Summary

Irritable Bowel Syndrome (IBS) is a gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits in the absence of any organic cause. Patients with IBS visit the doctor more frequently, use more diagnostic tests, consume more medications, miss more workdays, and consume more overall direct costs than patients without IBS. More specific treatment of the localized symptoms of IBS is therefore needed, why the present study will investigate the effect and mechanisms of PPC-5650. PPC-5650 is a new chemical entity that can negatively modulate the activity of Acid sensing ion channels (ASICs). It is a potent low molecular weight inhibitor for this class of ion channels described to date. It is hypothesized that safety, efficacy and mechanisms of local administration in the rectum of PPC-5650 can be evaluated by use of experimental induced sensation and pain in the rectum.

Phase: Phase 1

Sponsor: Aros Pharma ApS