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Treatment of Functional Bowel Disorders

Primary Purpose

Irritable Bowel Syndrome, Constipation, Abdominal Pain

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Desipramine
Cognitive Behavioral Treatment
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Functional bowel disorder, Irritable bowel syndrome, Painful constipation, Unspecified functional bowel disorder, Chronic functional abdominal pain, Cognitive-behavioral psychological treatment, IBS, CFAP

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Literate, female patients aged 18-65. Symptoms present at least 2 days/week for greater than 6 months. Diagnosis of functional bowel disorder (to be subcategorized using ''Rome'' Criteria. Moderate (MFBD) or severe (SFBD) functional bowel disorder (FBD) based on the Functional Bowel Disorder Severity Index (FBDSI) developed in our pilot study. SFBD will be defined as a score of 110 and MFBD will be defined as a score between 36 and 110. Discontinuation of all antidepressant medications for at least 3 months. Use of acceptable method of birth control. Exclusion Criteria: Evidence of lactose intolerance to explain bowel symptoms. Heart disease. Cardiac arrhythmias. Severe psychiatric disorder (e.g., bipolar, suicide attempts). Previous use of desipramine. Glaucoma. Urinary retention. Pregnancy. Alcohol consumption 3oz/day that would preclude participation or prevent data assessment. Systemic gastrointestinal diseases or previous surgery that would interfere with the interpretation of symptoms or physiology. Bipolar disorder. Schizophrenia. Substance abuse/dependency. Previous use of desipramine.

Sites / Locations

  • UNC Center for Functional GI Motility Disorders
  • Centre for Addiction and Mental Health, Clark Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 8, 2000
Last Updated
January 12, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00006157
Brief Title
Treatment of Functional Bowel Disorders
Official Title
Multicenter Trial of Functional Bowel Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

Brief Summary
The primary purpose for this study is to compare clinical treatments for patients with functional bowel disorders (irritable bowel syndrome, abdominal pain, painful constipation) in women. We also plan to: 1) determine what clinical features (medical or psychological) determine which patients will improve to these treatments, and 2) understand if there are any physiological features that relate to improvement in symptoms and response to the treatments. We will compare a psychological treatment (cognitive-behavioral therapy - CBT) with education/attention placebo, and an antidepressant drug (desipramine) with a pill placebo. This is the first large-scale study designed to determine the therapeutic effects of these methods, and to also determine interactions among physiologic measures, psychologic and sociodemographic factors, severity of symptoms, and therapeutic improvement including quality of life.
Detailed Description
Female patients (aged 18-65) with FBD (irritable bowel syndrome, painful constipation and/or functional abdominal pain) will be enrolled at UNC-Chapel Hill and Toronto, Canada. A severity index will determine recruitment into the group of moderate FBD (200 patients) and severe FBD (100 patients). Each group will be randomized into the three treatment arms (cognitive-behavioral treatment, desipramine, and education/attention placebo), treated over a 12-week period, and followed for one year. Outcome measures will include symptoms (standardized abdominal pain, stool form and frequency) using diary cards, daily functional status (Sickness Impact Profile), depression (HAM-D) and psychological distress (SCL-90), physiological measures (enhanced rectal motility and visceral sensation), and health care use. Multivariate statistical methods with a hierarchical design will be applied to the data to assure maintenance of statistical power over multiple tests of overlapping groups. The results of this study should significantly improve our understanding of this complicated syndrome that lowers the quality of life and economic productivity of large numbers of women. The clinical impact of the study, in providing physicians with scientific evidence of the efficacy of treatments of FBD that are commonly used in practice, is significant. We anticipate that this study will provide clinicians with predictors of success among types of FBD patients and types of therapy that will improve symptoms and quality of life, and reduce the health care costs associated with this common syndrome while improving patient-physician satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Constipation, Abdominal Pain, Functional Colonic Diseases
Keywords
Functional bowel disorder, Irritable bowel syndrome, Painful constipation, Unspecified functional bowel disorder, Chronic functional abdominal pain, Cognitive-behavioral psychological treatment, IBS, CFAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Desipramine
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Literate, female patients aged 18-65. Symptoms present at least 2 days/week for greater than 6 months. Diagnosis of functional bowel disorder (to be subcategorized using ''Rome'' Criteria. Moderate (MFBD) or severe (SFBD) functional bowel disorder (FBD) based on the Functional Bowel Disorder Severity Index (FBDSI) developed in our pilot study. SFBD will be defined as a score of 110 and MFBD will be defined as a score between 36 and 110. Discontinuation of all antidepressant medications for at least 3 months. Use of acceptable method of birth control. Exclusion Criteria: Evidence of lactose intolerance to explain bowel symptoms. Heart disease. Cardiac arrhythmias. Severe psychiatric disorder (e.g., bipolar, suicide attempts). Previous use of desipramine. Glaucoma. Urinary retention. Pregnancy. Alcohol consumption 3oz/day that would preclude participation or prevent data assessment. Systemic gastrointestinal diseases or previous surgery that would interfere with the interpretation of symptoms or physiology. Bipolar disorder. Schizophrenia. Substance abuse/dependency. Previous use of desipramine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas A. Drossman, M.D.
Organizational Affiliation
Univ of North Carolina at Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William E. Whitehead, PhD
Organizational Affiliation
Univ of North Carolina at Chapel Hill
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Brenda Toner, PhD
Organizational Affiliation
Centre for Addiction and Mental Health, Clark Site
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nick Diamant, MD
Organizational Affiliation
The Toronto Western Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
UNC Center for Functional GI Motility Disorders
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7080
Country
United States
Facility Name
Centre for Addiction and Mental Health, Clark Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.med.unc.edu/ibs
Description
The website for the UNC Center for Functional GI and Motility Disorders contains information on our center, functional bowel disorders, current clinical trials, and other FBD resources.

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Treatment of Functional Bowel Disorders

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