Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Status: | Terminated |
---|---|
Conditions: | Irritable Bowel Syndrome (IBS) |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | June 2013 |
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (RESTORE)
The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by
rectal distention in female patients with IBS-D
rectal distention in female patients with 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:
- improvement with defecation
- onset associated with a change in frequency of stool/defecation
- 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 Chron'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
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