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)

Overview

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).

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2014

Interventions

  • Drug: ONO-2952
  • Drug: ONO-2952 Matching Placebo

Arms, Groups and Cohorts

  • Experimental: Experimental Arm 1
    • ONO-2952 low dose every day for 4 weeks
  • Experimental: Experimental Arm 2
    • ONO-2952 high dose every day for 4 weeks
  • Placebo Comparator: Placebo Arm
    • ONO-2952 Matching Placebo every day for 4 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS)
    • Time Frame: 4 weeks

Secondary Measures

  • Change in IBS related symptoms and quality of life (QoL) by questionaire assessments
    • Time Frame: 4 weeks
  • Safety assessed through adverse events and clinical laboratory values
    • Time Frame: 4 weeks

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ono Pharma USA Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ono Pharma USA, Inc., Study Director, Ono Pharmaceutical Co. Ltd

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