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NCT00584571 · ClinicalTrials.gov registry record · Phase 2
SAT vs Escitalopram for Rectal Hypersensitivity
A Phase 2 study of Rectal Hypersensitivity and Irritable Bowel Syndrome-Constipation, sponsored by Augusta University.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 2
- Study locations
NCT00584571: Completed Phase 2 study of Rectal Hypersensitivity and Irritable Bowel Syndrome-Constipation, sponsored by Augusta University.
NCT00584571 is a Phase 2 study of Rectal Hypersensitivity and Irritable Bowel Syndrome-Constipation that has completed, run by Augusta University. The registered enrollment target is 55 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00584571, a Phase 2 study of Rectal Hypersensitivity and Irritable Bowel Syndrome-Constipation, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 2
- Study locations
Study Summary
Constipation is a common digestive disorder. After excluding dietary factors, drugs and other secondary causes, at least three broad pathophysiologic subtypes are recognized- dyssynergic defecation, constipation-predominant irritable bowel syndrome (IBS-C) and slow transit constipation (STC), all predominantly affect women and elderly. Many patients also demonstrate abnormal rectal perception with both rectal hyposensitivity and hypersensitivity being common. Recent surveys show that most constipated patients are dissatisfied with current therapy. Also, constipated patients showed significant psychological dysfunction and impaired quality of life. OBJECTIVE: To investigate a novel biofeedback technique of improving rectal hypersensitivity. METHODS: A large compliant balloon attached to a barostat was placed in the rectum in 8 patients with rectal hypersensitivity (urgency/pain threshold \<30 mm Hg). Sensory deconditioning was performed by incremental balloon distensions (1-2 mmHg) until normal thresholds were reached.
Conditions Studied
Interventions
- PROCEDURE Sensory Adaptation Training
- DRUG Escitalopram Therapy
Study Locations (2)
Georgia
- Augusta University - Augusta
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2007-12 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00584571
The ClinicalTrials.gov registry entry for NCT00584571 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Rectal Hypersensitivity appearing as the primary indexed condition, and to 2 interventions - of which Sensory Adaptation Training is the first listed.
NCT00584571 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Georgia, Iowa.
Frequently Asked Questions
What is clinical trial NCT00584571 about?
NCT00584571 is a clinical study titled "SAT vs Escitalopram for Rectal Hypersensitivity". Constipation is a common digestive disorder. After excluding dietary factors, drugs and other secondary causes, at least three broad pathophysiologic subtypes are recognized- dyssynergic defecation, constipation-predominant irritable bowel syndrome (IBS-C) and slow transit constipation (STC), all pr...
What is the current status of trial NCT00584571?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2007-12. Estimated completion is 2019-12-31.
What conditions does trial NCT00584571 study?
This clinical trial studies the following conditions: Rectal Hypersensitivity, Irritable Bowel Syndrome-Constipation.
What interventions are being tested in trial NCT00584571?
The interventions under investigation include: Sensory Adaptation Training (PROCEDURE), Escitalopram Therapy (DRUG).
Who is sponsoring clinical trial NCT00584571?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00584571 being conducted?
This trial has 2 study locations across Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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