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)



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

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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)

The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by
rectal distention in female patients with 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:

- improvement with defecation

- onset associated with a change in frequency of stool/defecation

- 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 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
We found this trial at
4
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St. Louis, Missouri 63110
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Boston, Massachusetts 02215
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Chapel Hill, North Carolina 27599
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Oklahoma, Oklahoma 73160
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Oklahoma, OK
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