Open Label Seroquel Study for TR IBS - Full Text View

Sponsor:	University of North Carolina
Collaborator:	AstraZeneca
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00617396

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.

Condition	Intervention
Functional Bowel Disorders	Drug: quetiapine

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders

Resource links provided by NLM:

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Treatment response to both binary and ordinal measures determine efficacy of Seroquel in treating refractory and treatment resistant functional bowel disorders. Specifically, daily, weekly and monthly responder status will be evaluated. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Repeated measures analysis using mixed effects models of primary outcomes of relief will be conducted to look for individual patient trajectories as they relate to dosage of Seroquel. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
a: Experimental	Drug: quetiapine Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100mgs for the remainder of the study. (8 weeks total)

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617396

Contacts

Contact: Kim Meyer, BS

919096608328

kimmey@med.unc.edu

Sponsors and Collaborators

University of North Carolina

AstraZeneca

Investigators

Principal Investigator:

Douglas Drossman, MD

UNC Chapel Hill

More Information

No publications provided

Responsible Party:	UNC Chapel Hill ( Douglas Drossman, MD )
Study ID Numbers:	IRUSQUET0448, IRB #07-1209
Study First Received:	February 5, 2008
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00617396 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Intestinal Diseases

Antipsychotic Agents
Pharmacologic Actions
Quetiapine
Pathologic Processes
Digestive System Diseases
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010