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

Sponsor:	Mclean Hospital
Collaborator:	Eli Lilly and Company
Information provided by:	Mclean Hospital
ClinicalTrials.gov Identifier:	NCT00401258

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 IV

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

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain Anxiety Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401258

Locations

United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478

Sponsors and Collaborators

Mclean Hospital

Eli Lilly and Company

Investigators

Principal Investigator:

Brian P Brennan, MD

Mclean Hospital

More Information

Publications:

Brennan BP, Fogarty KV, Roberts JL, Reynolds KA, Pope HG Jr, Hudson JI. Duloxetine in the treatment of irritable bowel syndrome: an open-label pilot study. Hum Psychopharmacol. 2009 Jul;24(5):423-8.

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 February 09, 2012