An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome Without Comorbid Major Depressive Disorder|
- Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994). [ Time Frame: baseline and week 12 ] [ Designated as safety issue: No ]Subjects rated abdominal pain daily on a scale of 0-10 (0 being no pain and 10 being worst pain). The pain score at each visit represented the mean score from all days since the previous visit.
- Brief Pain Inventory [ Time Frame: At each visit ] [ Designated as safety issue: No ]
- Short Form McGill Pain Questionnaire [ Time Frame: At each visit ] [ Designated as safety issue: No ]
- Clinical Global Impression Scale [ Time Frame: At each visit ] [ Designated as safety issue: No ]
- Hamilton Depression Rating Scale [ Time Frame: At first visit only ] [ Designated as safety issue: No ]
- Hamilton Anxiety Rating Scale [ Time Frame: At visits 2, 5, 7, and 9 ] [ Designated as safety issue: No ]
- Irritable Bowel Syndrome-Quality of Life Scale [ Time Frame: At each visit ] [ Designated as safety issue: No ]
- Sheehan Disability Scale [ Time Frame: At each visit ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
12-week, open-label trial of duloxetine in subjects with IBS.
30mg oral duloxetine per day for one week, titrated up to 60mg per day at day 8, concluded by a one week taper period of 4 days of 30mg pills at the conclusion of the study, followed by 3 days on no medication (4+3 days=1 week), concluded with a post-taper follow-up appointment with a study physician.
Other Name: Cymbalta
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.
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||Brian P Brennan, MD||Mclean Hospital|