Trial Outcomes & Findings for Open Label Seroquel (Quetiapine) Study for Treatment Resistant Functional Bowel Disorder (NCT NCT00617396)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-09-15

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	Quetiapine ( 50mg/Day -100mg/Day) 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.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quetiapine ( 50mg/Day -100mg/Day) n=25 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38.8 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: There was no exact statistical test used to determine the sample size. It is based on the capacity of site to recruit subjects.

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.

Outcome measures

Outcome measures
Measure	Quetiapine ( 50mg/Day -100mg/Day) n=25 Participants 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.
Adequate Relief in Pain Score During Treatment	52.6 percentage of subjects 2.0

Adverse Events

Quetiapine ( 50mg/Day -100mg/Day)

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Quetiapine ( 50mg/Day -100mg/Day) n=25 participants at risk 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.
Nervous system disorders cerebrovascular accident	4.0% 1/25 • Number of events 1 • 3 years

Other adverse events

Other adverse events
Measure	Quetiapine ( 50mg/Day -100mg/Day) n=25 participants at risk 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.
Nervous system disorders Drowsiness	92.0% 23/25 • Number of events 23 • 3 years
Musculoskeletal and connective tissue disorders tiredness	68.0% 17/25 • Number of events 17 • 3 years
Gastrointestinal disorders worsening abdominal pain or discomfort	16.0% 4/25 • Number of events 4 • 3 years

Additional Information

Dr. Douglas Drossman

UNC Chapel Hill

Phone: 919-966-0141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place