Expired Study
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Chapel Hill, North Carolina 27599


Purpose:

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.


Study summary:

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 these patients are diagnosed with irritable bowel syndrome, painful functional constipation or functional abdominal pain syndrome using Rome III criteria. The presenting symptoms of the referral population are frequently in the severe range, with patients having intensely painful symptoms, Axis I and Axis II co-morbidities, and impaired health related quality of life. Failure of multiple standard treatment attempts prior to referral is customary for patients seen in our clinic. Additionally, a greater number of patients only experience a partial response to standard treatment. We are therefore attempting to address these patients utilizing novel treatment strategies such as we propose here.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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


Study is Available At:


Original ID:

IRUSQUET0448


NCT ID:

NCT00617396


Secondary ID:


Study Acronym:


Brief Title:

Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder


Official Title:

An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of North Carolina, Chapel Hill


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Overall Contact Information

Official Name:Douglas A Drossman, MD
Principal Investigator
UNC Chapel Hill

Study Dates

Start Date:February 2008
Completion Date:May 2012
Completion Type:Actual
Primary Completion Date:January 2012
Primary Completion Type:Actual
Verification Date:February 2014
Last Changed Date:September 13, 2017
First Received Date:February 5, 2008
First Results Date:July 12, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Adequate Relief in Pain Score During Treatment
Time Frame:8 weeks
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Drug
Name:Quetiapine (50 mg/day-100mg/day)
Description:Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100mgs for the remainder of the study. (8 weeks total)
Arm Name:Quetiapine treatment group
Other Name:Seroquel

Study Arms

Study Arm Type:Experimental
Arm Name:Quetiapine treatment group
Description:All subjects will receive seroquel treatment for 8 weeks. Seroquel is the intervention.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of North Carolina, Chapel Hill
Agency Class:Industry
Agency Type:Collaborator
Agency Name:AstraZeneca

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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