Overview

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
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
Summary
The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ono Pharma USA Inc
Criteria
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