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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: Completed NA study, sponsored by University of North Carolina, Chapel Hill.
NCT00617396 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Biweekly relief in pain Biweekly subjects were asked whether they had adequate relief of pain. It was binary questionnaire i.e.- " Did you have adequate relief of pain in last two weeks? 1) yes 2) no The measure is percentage of subjects who said yes who had adequate relief of pain.
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 |
What the finished NCT00617396 record still lists
NCT00617396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Quetiapine (50 mg/day-100mg/day) is the first listed.
NCT00617396 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00617396's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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