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

Completed · Phase 4

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT00401258

Run by

Mclean Hospital

People needed

15

Starts

2006-11-01

Expected to finish

2008-02-01

Last updated by the study team

2018-03-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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