Treatment of Functional Bowel Disorders
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|ClinicalTrials.gov Identifier: NCT00006157|
Recruitment Status : Completed
First Posted : August 9, 2000
Last Update Posted : January 13, 2010
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 or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome Constipation Abdominal Pain Functional Colonic Diseases||Drug: Desipramine Behavioral: Cognitive Behavioral Treatment||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Official Title:||Multicenter Trial of Functional Bowel Disorders|
|Study Start Date :||July 1996|
|Estimated Study Completion Date :||March 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006157
|United States, North Carolina|
|UNC Center for Functional GI Motility Disorders|
|Chapel Hill, North Carolina, United States, 27599-7080|
|Centre for Addiction and Mental Health, Clark Site|
|Toronto, Ontario, Canada, M5T 1R8|
|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|