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)

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Irritable Bowel Syndrome (IBS)

Intervention / Treatment
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* Drug: ONO-2952
* Drug: ONO-2952 Matching Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18-65 years of age (inclusive) 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm 1<br>ONO-2952 low dose every day for 4 weeks | Drug: ONO-2952<br> <br> |
| Experimental: Experimental Arm 2<br>ONO-2952 high dose every day for 4 weeks | Drug: ONO-2952<br> <br> |
| Placebo Comparator: Placebo Arm<br>ONO-2952 Matching Placebo every day for 4 weeks | Drug: ONO-2952 Matching Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, IBS, ONO-2952