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Trial record 33 of 452 for:    QUETIAPINE

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

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ClinicalTrials.gov Identifier: NCT00617396
Recruitment Status : Completed
First Posted : February 18, 2008
Results First Posted : March 21, 2014
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Functional Bowel Disorders
Intervention Drug: Quetiapine (50 mg/day-100mg/day)
Enrollment 25
Recruitment Details Subjects were recruited from UNC GI outpatient clinic. Other recruitment strategies like newspaper ads, UNC mass emails and flyers were used. Recruitment started around 12/2007.
Pre-assignment Details This was 13 week long study which included 1 week of screning period followed by 4 weeks of treatment phase and 4 weeks of follow up period. During the screening visit following procedures were done- informed consent,medical history and demographics collection Vitals including abdominal girth,physical examination baseline labs and questionnaires
Arm/Group Title Quetiapine ( 50mg/Day -100mg/Day)
Hide Arm/Group Description There is only one group. All Subjects begin with a dose quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. 25 subjects were enrolled in this group.
Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Quetiapine ( 50mg/Day -100mg/Day)
Hide Arm/Group Description There is only one group. All Subjects begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total) 25 subjects were enrolled in this group.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
Subjects who received the investigational medication were analyzed. 4 subjects did not meet the study inclusion/exclusion criteria and were not analyzed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
38.8  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
25
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Adequate Relief in Pain Score During Treatment
Hide 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 had adequate relief of pain.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
There was no exact statistical test used to determine the sample size. It is based on the capacity of site to recruit subjects.
Arm/Group Title Quetiapine ( 50mg/Day -100mg/Day)
Hide Arm/Group Description:
There is only one group. All Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)30 subjects were enrolled in this group.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: percentage of subjects
52.6
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine ( 50mg/Day -100mg/Day)
Hide Arm/Group Description There is only one group. All Subject begin with a dose Quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)29 subjects were enrolled in this group.
All-Cause Mortality
Quetiapine ( 50mg/Day -100mg/Day)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine ( 50mg/Day -100mg/Day)
Affected / at Risk (%) # Events
Total   1/25 (4.00%)    
Nervous system disorders   
cerebrovascular accident  1  1/25 (4.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine ( 50mg/Day -100mg/Day)
Affected / at Risk (%) # Events
Total   23/25 (92.00%)    
Gastrointestinal disorders   
worsening abdominal pain or discomfort  1  4/25 (16.00%)  4
Musculoskeletal and connective tissue disorders   
tiredness  1  17/25 (68.00%)  17
Nervous system disorders   
Drowsiness  1  23/25 (92.00%)  23
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
  1. Uncontrolled open label study and is vulnerable to biases favoring a treatment response.
  2. Sample size is small.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Douglas Drossman
Organization: UNC Chapel Hill
Phone: 919-966-0141
EMail: douglas_drossman@med.unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00617396     History of Changes
Other Study ID Numbers: IRUSQUET0448
First Submitted: February 5, 2008
First Posted: February 18, 2008
Results First Submitted: July 12, 2013
Results First Posted: March 21, 2014
Last Update Posted: September 15, 2017