A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).
Inclusion Criteria:
Female 18-65 years of age (inclusive)
Diagnosed with IBS based on the following criteria (Rome III criteria):
Symptom onset at least 6 months prior to diagnosis, and
Recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and
Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:
Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations
Exclusion Criteria:
West Palm, Florida 33409, United States
Highpoint, North Carolina 27262, United States
Landsdale, Pennsylvania 19446, United States