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

NCT00401258 | Completed Phase 4 Results

• 1 other identifier: 2006-P-001723
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; irritable bowel syndrome; irritable bowel

Outcome Measures

Primary Outcomes (1)

• Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994).

  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.

  baseline and week 12

Secondary Outcomes (7)

• Brief Pain Inventory

  At each visit

• Short Form McGill Pain Questionnaire

  At each visit

• Clinical Global Impression Scale

  At each visit

• Hamilton Depression Rating Scale

  At first visit only

• Hamilton Anxiety Rating Scale

  At baseline and week 12

Study Arms (1)

1

OTHER

12-week, open-label trial of duloxetine in subjects with IBS.

Drug: duloxetine

Interventions

duloxetine DRUG

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.

Also known as: Cymbalta

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (1)

• 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. doi: 10.1002/hup.1038.

  PMID: 19548294 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Brian Brennan, M.D.
• Organization: McLean Hospital

bbrennan@partners.org

617-855-2911

Study Officials

• Brian P Brennan, MD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Translational Neuroscience Research

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 20, 2006
• Study Start: November 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 9, 2018
• Results First Posted: August 27, 2010

Record last verified: 2018-02

Locations

US (1)