Abstract
Summary
This document provides a short summary of the
This summary may help people with irritable bowel syndrome with constipation (IBS-C) and their family members and/or caregivers better understand the long-term safety of
The • The FDA is responsible for public health in the United States and makes sure that medicines are safe and effective.
The medicine development process starts with laboratory and animal testing. Once a potential medicine has been identified and proven to be safe and effective in animals, it is tested in humans in phase I, phase II, and phase III studies.
Diarrhea was the most common side effect in the three A side effect is something (expected or unexpected) that you feel was caused by a medicine or treatment you take. Side effects were similar to those reported by researchers in previous studies. No new safety issues were found with long-term use of
Footnotes
Acknowledgements
We would like to thank the patients and investigators who took part in the study. Plain language summary writing and editorial support for this report were provided by Katherine Cashell, BSc, Danielle Hirsch, PhD, and Kelsey Gribbon, MS, of Ashfield MedComms (New York, NY, USA), an Inizio company, and funded by Ardelyx, Inc. (Waltham, MA, USA).