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NCT00006157 · ClinicalTrials.gov registry record · Phase 3
Treatment of Functional Bowel Disorders
A Phase 3 study of Constipation and Irritable Bowel Syndrome, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 2
- Study locations
NCT00006157: Completed Phase 3 study of Constipation and Irritable Bowel Syndrome, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00006157 is a Phase 3 study of Constipation and Irritable Bowel Syndrome that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 300 participants, above the 200-participant average among 54 other Constipation trials with a reported enrollment target (50% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006157, a Phase 3 study of Constipation and Irritable Bowel Syndrome, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 2
- Study locations
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 |
What the finished NCT00006157 record still lists
NCT00006157 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 200-participant average among 54 other Constipation trials with a reported enrollment target (50% higher).
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.
NCT00006157 reports a single indexed study location in North Carolina, Ontario.
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.
What interventions are being tested in trial NCT00006157?
The interventions under investigation include: Desipramine (DRUG), Cognitive Behavioral Treatment (BEHAVIORAL).
Who is sponsoring clinical trial NCT00006157?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Constipation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00006157's enrollment target sits among peer trials
300 5th of 54 higher than 48 of 54 other Constipation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Constipation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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