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NCT00610909 · ClinicalTrials.gov registry record · Phase 4
Paroxetine - Controlled Release in the Treatment of Irritable Bowel Syndrome (IBS)
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT00610909 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 60 participants.
The verdict
NCT00610909, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
Irritable bowel syndrome (IBS) is an extremely common disorder in the U.S population, affecting somewhere between 9-22% based on community based studies. IBS has a chronic relapsing course and overlaps with other functional gastrointestinal disorders. It accounts for high direct medical expenses and indirect costs including a significant degree of absenteeism. Most studies have suggested that there is a slight predominance among women, especially those that have suffered some form of physical or sexual trauma. It has been estimated that up to 25-40% of patients seen by gastroenterologists' are affected by IBS, and that 70-90% of these patients may have a psychiatric comorbidity, most commonly major depression and panic disorder, but also including schizophrenia, double depression, dysthymia and alcohol abuse. Abdominal pain and disturbance of bowel habits characterize the symptoms of IBS in the absence of demonstrable structural pathology. The diagnosis of IBS relies upon clinical criteria alone, as there is no "gold standard" in laboratory findings. The diagnosis is dependent upon identifying characteristic symptoms, and then differentiating IBS from other structural bowel disorders. Previously, the diagnosis of IBS was based upon a consortium recommendation that examined and defined diagnostic criteria for over 100 functional gastrointestinal disorders. These criteria became the most definitive in the area of functional disorders and are referred to as the Rome Criteria. During the time since this consensus, these criteria have been modified, and in 1999 became the foundation for the second set of diagnostic criteria by consensus, now referred to as the Rome II criteria. The revised Rome II criteria include only the first part of the original criteria, but now require the presence of two out of three symptoms relating abdominal pain to bowel symptoms. We designed our study and a Randomized, double-blind, parallel-group, flexible-dose, placebo-controlled 12-week
Interventions
- DRUG Placebo
- DRUG Paroxetine CR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2002-01 |
| Est. Completion | 2002-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00610909
The ClinicalTrials.gov registry entry for NCT00610909 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00610909 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00610909 about?
NCT00610909 is a clinical study titled "Paroxetine - Controlled Release in the Treatment of Irritable Bowel Syndrome (IBS)". Irritable bowel syndrome (IBS) is an extremely common disorder in the U.S population, affecting somewhere between 9-22% based on community based studies. IBS has a chronic relapsing course and overlaps with other functional gastrointestinal disorders. It accounts for high direct medical expenses and...
What is the current status of trial NCT00610909?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2002-01. Estimated completion is 2002-12.
What interventions are being tested in trial NCT00610909?
The interventions under investigation include: Placebo (DRUG), Paroxetine CR (DRUG).
Who is sponsoring clinical trial NCT00610909?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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