Phase 4
N=15
An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00401258 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: Primary: Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994). — -1.5 Units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- duloxetine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mclean Hospital
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994). |
-1.5 | <0.001 sig |
| SECONDARY Brief Pain Inventory |
-1.5; -1.6 | <.001 sig |
| SECONDARY Short Form McGill Pain Questionnaire |
-2.37 | .001 sig |
| SECONDARY Clinical Global Impression Scale |
-1.7 | <0.001 sig |
| SECONDARY Hamilton Depression Rating Scale |
6.7 | — |
| SECONDARY Hamilton Anxiety Rating Scale |
-3.3 | 0.031 sig |
| SECONDARY Irritable Bowel Syndrome-Quality of Life Scale |
14.8 | <0.001 sig |
| SECONDARY Sheehan Disability Scale |
-2.5; -1.8; -2.2 | 0.004 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00401258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.