Treatment of Functional Bowel Disorders

NCT00006157 | Completed Phase 3

• 2 other identifiers: FBD (completed)R01DK049334
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Interventions

Desipramine DRUG

Cognitive Behavioral Treatment BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (2)

UNC Center for Functional GI Motility Disorders

Chapel Hill, North Carolina, 27599-7080, United States

Location

Centre for Addiction and Mental Health, Clark Site

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

• 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.

MeSH Terms

Conditions

Irritable Bowel Syndrome; Constipation; Abdominal Pain; Colonic Diseases, Functional

Interventions

Desipramine

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Douglas A. Drossman, M.D.

  Univ of North Carolina at Chapel Hill

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 8, 2000
• First Posted: August 9, 2000
• Study Start: July 1, 1996
• Study Completion: March 1, 2001
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

CA (1); US (1)