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NCT00617396 · ClinicalTrials.gov registry record · NA
Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT00617396 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 25 participants.
The verdict
NCT00617396, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
Purpose: We are proposing to examine, via open label trial, the use of Seroquel® for patients with moderate to severe functional bowel symptoms who are not receiving adequate relief from their symptoms on their present regimen of SNRI or TCA antidepressant agents. Participants: Primary eligibility will be determined of patients at The UNC Center for Functional GI \& Motility Disorders Clinic who score in the moderate to severe range on the Functional Bowel Disorders Severity Index (FBDSI ≥ 37) who have failed or have incomplete treatment responses of medications including at least one prior trial of antidepressant medication. Procedures (methods): We will monitor several patient and symptom related outcomes, as well as evaluate health related quality of life, psychological distress and related psychosocial measures to determine if the addition of Seroquel® over and above the use of an antidepressant improves clinical response based on an adequate relief measure as well as selected secondary outcomes. We will also determine when treatment benefit is related to effects on pain, the associated psychological co-morbidities seen in this population, or both factors.
Interventions
- DRUG Quetiapine (50 mg/day-100mg/day)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00617396
The ClinicalTrials.gov registry entry for NCT00617396 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Quetiapine (50 mg/day-100mg/day) is the first listed.
NCT00617396 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00617396 about?
NCT00617396 is a clinical study titled "Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder". Purpose: We are proposing to examine, via open label trial, the use of Seroquel® for patients with moderate to severe functional bowel symptoms who are not receiving adequate relief from their symptoms on their present regimen of SNRI or TCA antidepressant agents. Participants: Primary eligibility ...
What is the current status of trial NCT00617396?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2008-02. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00617396?
The interventions under investigation include: Quetiapine (50 mg/day-100mg/day) (DRUG).
Who is sponsoring clinical trial NCT00617396?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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