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

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Irritable Bowel Syndrome

Treatments

Drug: duloxetine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00401258

2006-P-001723

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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