Functional Bowel DisordersNCT00617396
Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder
A study testing Quetiapine (50 mg/day-100mg/day) in people with Functional Bowel Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Functional Bowel Disorders
- What is being tested?
- Quetiapine (50 mg/day-100mg/day)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center for Functional GI & Motility Disorders
Chapel Hill, North Carolina, 27599
About this study
Official title: An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders
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.
Read the 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.
- Conditions
- Functional Bowel Disorders
- Being tested
- Quetiapine (50 mg/day-100mg/day)
- Keywords
- Irritable Bowel Syndrome, Seroquel, Abdominal Pain
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine (50 mg/day-100mg/day)Drug
Also called Seroquel
Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100mgs for the remainder of the study. (8 weeks total)
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine treatment group | Experimental | All subjects will receive seroquel treatment for 8 weeks. Seroquel is the intervention. Receives: Drug: Quetiapine (50 mg/day-100mg/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate Relief in Pain Score During Treatment
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional Bowel DisordersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Douglas A Drossman, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617396
- Sponsor's protocol ID
- IRUSQUET0448
- Status last verified
- Feb 2014
- First submitted
- 5 Feb 2008
- Last updated
- 15 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders
- ClinicalTrials.gov ID
- NCT00617396
- Acronym / sponsor ID
- IRUSQUET0448
- Conditions
- Functional Bowel Disorders
- Keywords
- Irritable Bowel Syndrome, Seroquel, Abdominal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Feb 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Posted 21 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quetiapine treatment group | Experimental | Drug: Quetiapine (50 mg/day-100mg/day)All subjects will receive seroquel treatment for 8 weeks. Seroquel is the intervention. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine (50 mg/day-100mg/day)Also: SeroquelSubject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100mgs for the remainder of the study. (8 weeks total) | Drug | Quetiapine treatment group |
Primary outcome
Adequate Relief in Pain Score During Treatment
Time frame: 8 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas A Drossman, MD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quetiapine (50 mg/day-100mg/day) in people with Functional Bowel Disorders, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate Relief in Pain Score During Treatment (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.