Status:
COMPLETED
Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
AstraZeneca
Conditions:
Functional Bowel Disorders
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 symptom...
Detailed Description
The UNC Center for Functional GI \& Motility Disorders Clinic frequently receives referrals for patients with chronic and treatment refractory symptoms of abdominal pain and bowel dysfunction. Many of...
Eligibility Criteria
Inclusion
- The subject has been diagnosed with a painful functional bowel disorder lasting longer than six months
- The subject achieves a score greater than 37 on the Functional Bowel Disorders Severity Index
- Four weeks on anti-depressant medications did not lead to adequate relief of the GI symptoms
Exclusion
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance or lack of response to Seroquel as judged by the investigator
- Use of prohibited medicationsMedical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical
- An absolute neutrophil count (ANC) of ≤1.5 X 109 per liter
- Subject is pregnant or breastfeeding.
- Subject is taking other medication thought to directly affect gut function via the 5HT method of action (Tegaserod)
- Known hypersensitivity to duloxetine or any of the inactive ingredients in duloxetine
- Any patient taking Monoamine Oxidase Inhibitors
- Patient with uncontrolled narrow-angle glaucoma
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00617396
Start Date
February 1 2008
End Date
May 1 2012
Last Update
September 15 2017
Active Locations (1)
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1
UNC Center for Functional GI & Motility Disorders
Chapel Hill, North Carolina, United States, 27599