Status:
TERMINATED
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)
Lead Sponsor:
Ono Pharma USA Inc
Conditions:
Irritable Bowel Syndrome (IBS)
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01887002
Start Date
June 1 2013
Last Update
February 25 2016
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Boston Clinical Site
Boston, Massachusetts, United States, 02215
2
St. Louis Clinical Site
St Louis, Missouri, United States, 63110
3
Chapel Hill Clinical Site
Chapel Hill, North Carolina, United States, 27599
4
Oklahoma City Clinical Site
Oklahoma City, Oklahoma, United States, 73160