Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Phase 2

Terminated

• Conditions: Irritable Bowel Syndrome (IBS)
• Interventions: Drug: Placebo comparator; Drug: ONO-2952

• Registration Number: NCT01887002
• Lead Sponsor: Ono Pharma USA Inc

Brief Summary

The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-26
• Primary Completion: 2015-01
• Status Verified: 2016-01
• Disposition First Submitted: 2016-01-26
• Disposition First Submitted QC: 2016-01-26
• Last Update Submitted: 2016-01-26
• Disposition First Posted: 2016-02-25
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 39

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:
   • improvement with defecation
   • onset associated with a change in frequency of stool/defecation
   • 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 Chron'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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo comparator	ONO-2952 Matching Placebo every day for 2 weeks
Experimental Arm 1	ONO-2952	ONO-2952 Active tablets, every day for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change in pain intensity rating during rectal distention by using a numeric pain rating scale	2 weeks

Secondary Outcome Measures

Name	Time	Method
Safety assessed through adverse events and clinical laboratory values	2 weeks

Trial Locations

Locations (4)

St. Louis Clinical Site; 🇺🇸 St. Louis, Missouri, United States

Oklahoma City Clinical Site; 🇺🇸 Oklahoma, Oklahoma, United States

Boston Clinical Site; 🇺🇸 Boston, Massachusetts, United States

Chapel Hill Clinical Site; 🇺🇸 Chapel Hill, North Carolina, United States