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Treatment of Functional Bowel Disorders
NCT00006157 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Desipramine
- BEHAVIORAL Cognitive Behavioral Treatment
Study Locations (2)
North Carolina
- UNC Center for Functional GI Motility Disorders — Chapel Hill
Ontario
- Centre for Addiction and Mental Health, Clark Site — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 1996-07 |
| Est. Completion | 2001-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006157
The ClinicalTrials.gov registry entry for NCT00006157 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Constipation appearing as the primary indexed condition, and to 2 interventions — of which Desipramine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00006157 reports 2 study locations spanning 2 distinct geographic areas — top geographies include North Carolina, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00006157 about?
NCT00006157 is a clinical study titled "Treatment of Functional Bowel Disorders". 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 i...
What is the current status of trial NCT00006157?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 1996-07. Estimated completion is 2001-03.
What conditions does trial NCT00006157 study?
This clinical trial studies the following conditions: Constipation, Irritable Bowel Syndrome, Abdominal Pain, Functional Colonic Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00006157?
The interventions under investigation include: Desipramine (DRUG), Cognitive Behavioral Treatment (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00006157?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00006157 being conducted?
This trial has 2 study locations across North Carolina, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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