A Phase 2, Multi-center Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Status: | Completed |
---|---|
Conditions: | Irritable Bowel Syndrome (IBS) |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | April 2013 |
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).
female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).
Inclusion Criteria:
1. Female 18-65 years of age (inclusive)
2. 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:
1. Improvement with defecation
2. Onset associated with a change in frequency of stool/defecation
3. Onset associated with a change in form (appearance) of stool
3. Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤
25% of defecations
Exclusion Criteria:
- Any structural abnormality of the gastrointestinal (GI) tract (other than esophagitis
or gastritis)
- History of Crohn's disease, ulcerative colitis, diabetes mellitus, lactose
malabsorption, malabsorption syndromes, celiac sprue, or any upper GI symptoms that
may impact the assessment of IBS symptoms
We found this trial at
48
sites
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