Back to resultsStudy 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) (RESTORE)
Primary Purpose
Irritable Bowel Syndrome (IBS)
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ONO-2952
Placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome (IBS) focused on measuring Irritable Bowel Syndrome, IBS, ONO-2952
Eligibility Criteria
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 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
Sites / Locations
- Boston Clinical Site
- St. Louis Clinical Site
- Chapel Hill Clinical Site
- Oklahoma City Clinical Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Arm 1
Placebo Arm
Arm Description
ONO-2952 Active tablets, every day for 2 weeks
ONO-2952 Matching Placebo every day for 2 weeks
Outcomes
Primary Outcome Measures
Change in pain intensity rating during rectal distention by using a numeric pain rating scale
Secondary Outcome Measures
Safety assessed through adverse events and clinical laboratory values
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01887002
Brief Title
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)
Acronym
RESTORE
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled 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) (RESTORE)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to slow accrual of subjects.
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharma USA Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome (IBS)
Keywords
Irritable Bowel Syndrome, IBS, ONO-2952
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm 1
Arm Type
Experimental
Arm Description
ONO-2952 Active tablets, every day for 2 weeks
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
ONO-2952 Matching Placebo every day for 2 weeks
Intervention Type
Drug
Intervention Name(s)
ONO-2952
Intervention Description
ONO-2952 Active tablets, every day for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
ONO-2952 Matching Placebo every day for 2 weeks
Primary Outcome Measure Information:
Title
Change in pain intensity rating during rectal distention by using a numeric pain rating scale
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Safety assessed through adverse events and clinical laboratory values
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ono Pharma USA, Inc.
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Boston Clinical Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
St. Louis Clinical Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Chapel Hill Clinical Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Oklahoma City Clinical Site
City
Oklahoma
State/Province
Oklahoma
ZIP/Postal Code
73160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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)
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