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)
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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)
1 other identifier
interventional
200
1 country
48
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 24, 2013
CompletedFirst Posted
Study publicly available on registry
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedApril 15, 2016
March 1, 2016
1.2 years
April 24, 2013
March 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (3)
Experimental Arm 1
EXPERIMENTALONO-2952 low dose every day for 4 weeks
Experimental Arm 2
EXPERIMENTALONO-2952 high dose every day for 4 weeks
Placebo Arm
PLACEBO COMPARATORONO-2952 Matching Placebo every day for 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Anniston Clinical Site
Anniston, Alabama, 36207, United States
Goodyear Clinical Site
Goodyear, Arizona, 85351, United States
Tucson Clinical Site
Tucson, Arizona, 85712, United States
North Little Rock Clinical Site
North Little Rock, Arkansas, 72120, United States
Carlsbad Clinical Site
Carlsbad, California, 92008, United States
San Diego Clinical Site
San Diego, California, 92114, United States
Boynton Beach Clinical Site
Boynton Beach, Florida, 33426, United States
Clearwater Clinical Site
Clearwater, Florida, 33756, United States
Deland Clinical Site
DeLand, Florida, 32720, United States
Hialeah Clinical Site
Hialeah, Florida, 33012, United States
Lauderdale Lakes Clinical Site
Lauderdale Lakes, Florida, 33319, United States
Orlando Clinical Site
Orlando, Florida, 32806, United States
Port Orange Clinical Site
Port Orange, Florida, 32129, United States
South Miami Clinical Site
South Miami, Florida, 33143, United States
St. Petersburg Clinical Site
St. Petersburg, Florida, 33709, United States
Tampa Clinical Site
Tampa, Florida, 33606, United States
West Palm Clinical Site
West Palm, Florida, 33409, United States
Oak Lawn Clinical Site
Oak Lawn, Illinois, 60453, United States
Wichita Clinical Site
Wichita, Kansas, 67203, United States
New Orleans Clinical Site
New Orleans, Louisiana, 70115, United States
Chesterfield Clincial Site
Chesterfield, Michigan, 48047, United States
Billings Clinical Site
Billings, Montana, 59102, United States
Reno Clinical Site
Reno, Nevada, 89511, United States
Lebanon Clinical Site
Lebanon, New Hampshire, 03756, United States
Albuquerque Clinical Site
Albuquerque, New Mexico, 87102, United States
Great Neck Clinical Site
Great Neck, New York, 11023, United States
Cary Clinical Site
Cary, North Carolina, 27518, United States
Highpoint Clinical Site
Highpoint, North Carolina, 27262, United States
Raleigh Clinical Site
Raleigh, North Carolina, 27612, United States
Winston-Salem Clinical Site
Winston-Salem, North Carolina, 27103, United States
Akron Clinical Site
Akron, Ohio, 44311, United States
Columbus Clinical Site
Columbus, Ohio, 43212, United States
Dayton Clinical Site
Dayton, Ohio, 45432, United States
Groveport Clinical Site
Groveport, Ohio, 43125, United States
Mentor Clinical Site
Mentor, Ohio, 44060, United States
Norman Clinical Site
Norman, Oklahoma, 73069, United States
Lansdale Clinical Site
Landsdale, Pennsylvania, 19446, United States
Greer Clinical Site
Greer, South Carolina, 29650, United States
Mt. Pleasant Clinical Site
Mt. Pleasant, South Carolina, 29464, United States
Chattanooga Clinical Site
Chattanooga, Tennessee, 37421, United States
Germantown Clinical Site
Germantown, Tennessee, 38138, United States
Pasadena Clinical Site
Pasadena, Texas, 77505, United States
Plano Clinial Site
Plano, Texas, 75075, United States
San Antonio Clinical Site
San Antonio, Texas, 78229, United States
Logan Clinical Site
Logan, Utah, 84341, United States
Ogden Clinical Site
Ogden, Utah, 84405, United States
Salt Lake City Clinical Site
Salt Lake City, Utah, 84107, United States
Sandy Clinical Site
Sandy City, Utah, 84094, United States
Related Publications (1)
Whitehead WE, Duffy K, Sharpe J, Nabata T, Bruce M. Randomised clinical trial: exploratory phase 2 study of ONO-2952 in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2017 Jan;45(1):14-26. doi: 10.1111/apt.13839. Epub 2016 Nov 7.
PMID: 27910150DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ono Pharma USA, Inc.
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2013
First Posted
May 1, 2013
Study Start
April 1, 2013
Primary Completion
July 1, 2014
Last Updated
April 15, 2016
Record last verified: 2016-03