Status:
COMPLETED
An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
We hypothesize that duloxetine treatment will be associated with improvement in symptoms of IBS, particularly abdominal pain, in individuals without comorbid major depressive disorder. During this 12...
Detailed Description
IBS is a chronic gastrointestinal disorder characterized by abdominal pain, altered bowel habits, and abdominal bloating for which no organic cause can be determined. Duloxetine has demonstrated effic...
Eligibility Criteria
Inclusion
- 18-65 years of age
- Subjects must have been diagnosed with irritable bowel syndrome by a physician
- Subjects must have had gastrointestinal symptoms for 2 or more days per week for \> 6 months
Exclusion
- Lifetime history of bipolar disorder, psychotic disorder, or obsessive-compulsive disorder
- Current (within past 6 months) diagnosis of major depressive disorder or substance abuse disorder
- Active suicidal/homicidal ideation
- Pregnant women or women of child-bearing potential not using an approved methods of contraception
- Individuals with an unstable medical condition that in the opinion of the investigator would interfere with the interpretation of symptoms
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00401258
Start Date
November 1 2006
End Date
February 1 2008
Last Update
March 9 2018
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478