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)
NCT ID: NCT01844180
Last Updated: 2016-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental Arm 1
ONO-2952 low dose every day for 4 weeks
ONO-2952
Experimental Arm 2
ONO-2952 high dose every day for 4 weeks
ONO-2952
Placebo Arm
ONO-2952 Matching Placebo every day for 4 weeks
ONO-2952 Matching Placebo
Interventions
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ONO-2952
ONO-2952 Matching Placebo
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Ono Pharma USA Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Ono Pharma USA, Inc.
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Anniston Clinical Site
Anniston, Alabama, United States
Goodyear Clinical Site
Goodyear, Arizona, United States
Tucson Clinical Site
Tucson, Arizona, United States
North Little Rock Clinical Site
North Little Rock, Arkansas, United States
Carlsbad Clinical Site
Carlsbad, California, United States
San Diego Clinical Site
San Diego, California, United States
Boynton Beach Clinical Site
Boynton Beach, Florida, United States
Clearwater Clinical Site
Clearwater, Florida, United States
Deland Clinical Site
DeLand, Florida, United States
Hialeah Clinical Site
Hialeah, Florida, United States
Lauderdale Lakes Clinical Site
Lauderdale Lakes, Florida, United States
Orlando Clinical Site
Orlando, Florida, United States
Port Orange Clinical Site
Port Orange, Florida, United States
South Miami Clinical Site
South Miami, Florida, United States
St. Petersburg Clinical Site
St. Petersburg, Florida, United States
Tampa Clinical Site
Tampa, Florida, United States
West Palm Clinical Site
West Palm, Florida, United States
Oak Lawn Clinical Site
Oak Lawn, Illinois, United States
Wichita Clinical Site
Wichita, Kansas, United States
New Orleans Clinical Site
New Orleans, Louisiana, United States
Chesterfield Clincial Site
Chesterfield, Michigan, United States
Billings Clinical Site
Billings, Montana, United States
Reno Clinical Site
Reno, Nevada, United States
Lebanon Clinical Site
Lebanon, New Hampshire, United States
Albuquerque Clinical Site
Albuquerque, New Mexico, United States
Great Neck Clinical Site
Great Neck, New York, United States
Cary Clinical Site
Cary, North Carolina, United States
Highpoint Clinical Site
Highpoint, North Carolina, United States
Raleigh Clinical Site
Raleigh, North Carolina, United States
Winston-Salem Clinical Site
Winston-Salem, North Carolina, United States
Akron Clinical Site
Akron, Ohio, United States
Columbus Clinical Site
Columbus, Ohio, United States
Dayton Clinical Site
Dayton, Ohio, United States
Groveport Clinical Site
Groveport, Ohio, United States
Mentor Clinical Site
Mentor, Ohio, United States
Norman Clinical Site
Norman, Oklahoma, United States
Lansdale Clinical Site
Landsdale, Pennsylvania, United States
Greer Clinical Site
Greer, South Carolina, United States
Mt. Pleasant Clinical Site
Mt. Pleasant, South Carolina, United States
Chattanooga Clinical Site
Chattanooga, Tennessee, United States
Germantown Clinical Site
Germantown, Tennessee, United States
Pasadena Clinical Site
Pasadena, Texas, United States
Plano Clinial Site
Plano, Texas, United States
San Antonio Clinical Site
San Antonio, Texas, United States
Logan Clinical Site
Logan, Utah, United States
Ogden Clinical Site
Ogden, Utah, United States
Salt Lake City Clinical Site
Salt Lake City, Utah, United States
Sandy Clinical Site
Sandy City, Utah, United States
Countries
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References
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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.
Other Identifiers
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ONO-2952POU004
Identifier Type: -
Identifier Source: org_study_id
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