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
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• 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:

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