"The results of this study suggest that AMITIZA may help improve several of the most frequently reported symptoms of IBS-C, including abdominal pain, bloating and discomfort," said John Johanson, M.D., primary investigator and clinical associate professor, University of Illinois College of Medicine. "There are several additional studies underway that further explore the uses of AMITIZA in this patient population and we look forward to learning the findings."
AMITIZA is a novel selective chloride channel activator that has been shown to be effective and well-tolerated in a number of well-controlled clinical trials in patients with chronic idiopathic constipation. AMITIZA was approved for use for chronic idiopathic constipation in adults on January 31, 2006. This is the first time AMITIZA has been tested exclusively in the IBS-C population.
About the Study
In a double-blind, placebo-controlled, dose-ranging study, approximately 200 patients with diagnosed IBS-C (per the Rome II criteria) were randomized to receive placebo or AMITIZA (8, 16 or 24 micrograms) twice-daily for 12 weeks. In an electronic diary, patients recorded data related to dosing, side effects and IBS-C symptoms including bloating, abdominal pain/discomfort, frequency of and straining during bowel movements, stool consistency and rescue medication use.
Significant improvements versus placebo were observed for at least two of the three months for abdominal pain/discomfort, abdominal bloating, frequency of spontaneous bowel movements (SBM), sto
Contact: Jocelyn M. Gerst