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)



Status:Completed
Conditions:Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:April 2013

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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)

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).


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
We found this trial at
48
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North Little Rock, Arkansas 72120
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Akron, Ohio 44320
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Albuquerque, New Mexico 87131
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Anniston, Alabama 36207
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Billings, Montana 59102
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Boynton Beach, Florida 33426
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Carlsbad, California 92008
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Cary, North Carolina 27518
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Chattanooga, Tennessee 37421
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Chesterfield, Michigan 48047
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Clearwater, Florida 33756
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Columbus, Ohio 43212
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Dayton, Ohio 45432
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Deland, Florida 32720
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Germantown, Tennessee 38138
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Goodyear, Arizona 85351
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Great Neck, New York 11023
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Greer, South Carolina 29650
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Groveport, Ohio 43125
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Hialeah, Florida 33012
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HighPoint, North Carolina 27265
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Landsdale, Pennsylvania 19446
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Lauderdale Lakes, Florida 33319
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Lebanon, New Hampshire 03756
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Logan, Utah 84341
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Mentor, Ohio 44060
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Mt. Pleasant, South Carolina 29464
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New Orleans, Louisiana 70115
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Norman, Oklahoma 73069
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Oak Lawn, Illinois 60453
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Ogden, Utah 84341
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Orlando, Florida 32803
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Pasadena, Texas 77505
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Plano, Texas 75075
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Port Orange, Florida 32129
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Raleigh, North Carolina 27607
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Reno, Nevada 89511
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Salt Lake City, Utah 84107
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San Antonio, Texas 78229
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San Diego, California 92123
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Sandy, Utah 84094
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South Miami, Florida 33034
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St. Petersburg, Florida 33709
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Tampa, Florida 33606
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Tucson, Arizona 85741
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Wichita, Kansas 67203
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Winston-Salem, North Carolina 27103
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