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

Condition(s) targeted: Irritable Bowel Syndrome

Intervention: duloxetine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Mclean Hospital

Official(s) and/or principal investigator(s):
Brian P Brennan, MD, Principal Investigator, Affiliation: Mclean Hospital

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.

Official title: An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome Without Comorbid Major Depressive Disorder

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: Daily Pain Diary Assessment

Secondary outcome:

Brief Pain Inventory

Short Form McGill Pain Questionnaire

Clinical Global Impression Scale

Hamilton Depression Rating Scale

Hamilton Anxiety Rating Scale

Irritable Bowel Syndrome-Quality of Life Scale

Sheehan Disability Scale

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 efficacy in the treatment of depression as well as in several pain syndromes including diabetic peripheral neuropathy and fibromyalgia. We hypothesize that it will be a safe and efficacious treatment for the symptoms of IBS, in particular abdominal pain.

We plan to study 15 male and female subjects between the ages of 18 and 65 years who have had gastrointestinal symptoms at least 2 days/week for greater than six months and who have been diagnosed with IBS by a physician. During the 12-week study, subjects will receive open-label duloxetine titrated up to 60mg/day. Subjects will be asked to complete a total of ten study visits during the 12-week study period. All study visits will be conducted at McLean Hospital.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

McLean Hospital, Belmont, Massachusetts 02478, United States

Starting date: November 2006
Ending date: February 2008
Last updated: May 1, 2008