An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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-week, open-label, outpatient study, male and female subjects between the ages of 18 and 65 years who have been diagnosed with irritable bowel syndrome (IBS) will be treated with open-label duloxetine.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mclean Hospital
• Collaborator: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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