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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Greer, South Carolina 29650
2025
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Greer, SC
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Akron, Ohio 44320
2037
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Akron, OH
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Albuquerque, New Mexico 87131
648
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Anniston, Alabama 36207
1838
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Anniston, AL
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Billings, Montana 59102
949
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Billings, MT
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Boynton Beach, Florida 33426
2307
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Carlsbad, California 92008
75
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Cary, North Carolina 27518
2211
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Cary, NC
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Chattanooga, Tennessee 37421
1862
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Chesterfield, Michigan 48047
1983
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Clearwater, Florida 33756
2117
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Clearwater, FL
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Columbus, Ohio 43212
1958
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Columbus, OH
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Dayton, Ohio 45432
1902
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Dayton, OH
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Deland, Florida 32720
2177
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Deland, FL
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Germantown, Tennessee 38138
1600
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Germantown, TN
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Goodyear, Arizona 85351
327
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Goodyear, AZ
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Great Neck, New York 11023
2446
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Great Neck, NY
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Groveport, Ohio 43125
1966
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Groveport, OH
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Hialeah, Florida 33012
2313
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Hialeah, FL
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HighPoint, North Carolina 27265
2140
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HighPoint, NC
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Landsdale, Pennsylvania 19446
2367
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Landsdale, PA
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Lauderdale Lakes, Florida 33319
2310
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Lebanon, New Hampshire 03756
2515
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Logan, Utah 84341
627
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Mentor, Ohio 44060
2051
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Mentor, OH
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Mt. Pleasant, South Carolina 29464
2188
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New Orleans, Louisiana 70115
1654
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New Orleans, LA
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Norman, Oklahoma 73069
1168
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North Little Rock, Arkansas 72120
1463
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Oak Lawn, Illinois 60453
1722
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Oak Lawn, IL
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Ogden, Utah 84341
630
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Ogden, UT
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Orlando, Florida 32803
?
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Orlando, FL
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Pasadena, Texas 77505
1368
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Plano, Texas 75075
1225
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Plano, TX
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Port Orange, Florida 32129
2191
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Port Orange, FL
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Raleigh, North Carolina 27607
2214
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Raleigh, NC
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Reno, Nevada 89511
381
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Reno, NV
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Salt Lake City, Utah 84107
565
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Salt Lake City, UT
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San Antonio, Texas 78229
1188
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San Diego, California 92123
105
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Sandy, Utah 84094
561
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South Miami, Florida 33034
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St. Petersburg, Florida 33709
2123
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Tampa, Florida 33606
2137
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Tucson, Arizona 85741
420
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West Palm, Florida 33409
2301
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Wichita, Kansas 67203
1179
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Winston-Salem, North Carolina 27103
2122
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Winston-Salem, NC
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