Treatment of Functional Bowel Disorders

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00006157
First received: August 8, 2000
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Constipation
Abdominal Pain
Functional Colonic Diseases
Drug: Desipramine
Behavioral: Cognitive Behavioral Treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multicenter Trial of Functional Bowel Disorders

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 300
Study Start Date: July 1996
Estimated Study Completion Date: March 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006157

Locations
United States, North Carolina
UNC Center for Functional GI Motility Disorders
Chapel Hill, North Carolina, United States, 27599-7080
Canada, Ontario
Centre for Addiction and Mental Health, Clark Site
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Investigators
Principal Investigator: Douglas A. Drossman, M.D. Univ of North Carolina at Chapel Hill
Study Chair: William E. Whitehead, PhD Univ of North Carolina at Chapel Hill
Study Chair: Brenda Toner, PhD Centre for Addiction and Mental Health, Clark Site
Study Chair: Nick Diamant, MD The Toronto Western Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006157     History of Changes
Other Study ID Numbers: FBD (completed), RO1DK49334
Study First Received: August 8, 2000
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Functional bowel disorder
Irritable bowel syndrome
Painful constipation
Unspecified functional bowel disorder
Chronic functional abdominal pain
Cognitive-behavioral psychological treatment
IBS
CFAP

Additional relevant MeSH terms:
Abdominal Pain
Colonic Diseases
Colonic Diseases, Functional
Constipation
Gastrointestinal Diseases
Intestinal Diseases
Irritable Bowel Syndrome
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Digestive System Diseases
Desipramine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014