An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome |
Drug: duloxetine |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 15 |
| Study Start Date: | November 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
12-week, open-label trial of duloxetine in subjects with IBS.
|
Drug: duloxetine
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Massachusetts | |
| McLean Hospital | |
| Belmont, Massachusetts, United States, 02478 | |
| Principal Investigator: | Brian P Brennan, MD | Mclean Hospital |
More Information
Publications:
| Responsible Party: | Brian P. Brennan, M.D., McLean Hospital |
| ClinicalTrials.gov Identifier: | NCT00401258 History of Changes |
| Other Study ID Numbers: | 2006-P-001723 |
| Study First Received: | November 16, 2006 |
| Results First Received: | June 25, 2010 |
| Last Updated: | August 6, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mclean Hospital:
|
IBS irritable bowel syndrome irritable bowel |
Additional relevant MeSH terms:
|
Depressive Disorder Irritable Bowel Syndrome Depressive Disorder, Major Mood Disorders Mental Disorders Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013