Irritable Bowel Syndrome (IBS)
Conditions
Keywords
Irritable Bowel Syndrome, IBS, ONO-2952
Brief 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).
Interventions
Sponsors
Ono Pharma USA Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in IBS related symptoms and quality of life (QoL) by questionaire assessments | 4 weeks |
| Safety assessed through adverse events and clinical laboratory values | 4 weeks |
Countries
United States
Outcome results
None listed