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) (RESTORE)

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome (IBS)

Treatments: Drug: ONO-2952; Drug: ONO-2952 Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01844180

ONO-2952POU004

Details and patient eligibility

About

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).

Enrollment: 200 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 3 patient groups, including a placebo group

Experimental Arm 1

Experimental group

Description:

ONO-2952 low dose every day for 4 weeks

Treatment:

Drug: ONO-2952

Experimental Arm 2

Experimental group

Description:

ONO-2952 high dose every day for 4 weeks

Treatment:

Drug: ONO-2952

Placebo Arm

Placebo Comparator group

Description:

ONO-2952 Matching Placebo every day for 4 weeks

Treatment:

Drug: ONO-2952 Matching Placebo