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)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Irritable Bowel Syndrome (IBS)
In brief
The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D
Key facts
- Study ID
- NCT01887002
- Run by
- Ono Pharma USA Inc
- People needed
- 39
- Starts
- 2013-06-01
- Last updated by the study team
- 2016-02-25
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
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 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
Where it is running
- Boston Clinical Site — Boston, Massachusetts, United States
- St. Louis Clinical Site — St Louis, Missouri, United States
- Chapel Hill Clinical Site — Chapel Hill, North Carolina, United States
- Oklahoma City Clinical Site — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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