Trial Outcomes & Findings for An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome (NCT NCT00401258)

Results Overview

Subjects rated abdominal pain daily on a scale of 0-10 (0 being no pain and 10 being worst pain). The pain score at each visit represented the mean score from all days since the previous visit.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

baseline and week 12

Results posted on

2018-03-09

Participant Flow

Participants were recruited through advertisements

Participant milestones

Participant milestones
Measure	Duloxetine, 60 mg Daily Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Overall Study STARTED	15
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Duloxetine, 60 mg Daily Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Overall Study Adverse Event	7

Baseline Characteristics

An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duloxetine, 60 mg Daily n=15 Participants Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44.5 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and week 12

Subjects rated abdominal pain daily on a scale of 0-10 (0 being no pain and 10 being worst pain). The pain score at each visit represented the mean score from all days since the previous visit.

Outcome measures

Outcome measures
Measure	Duloxetine, 60 mg Daily n=15 Participants Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994).	-1.5 Units on a scale Interval -2.3 to -0.7

SECONDARY outcome

Timeframe: At each visit

The Brief Pain Inventory is a self-administered questionnaire used to evaluate the severity of a patient's pain and its interference with their life. Four items measure pain severity on a scale of 0-10, with 0 being absence of pain and 10 being severe pain. Seven items measure pain interference on a scale of 0-10, with 0 being absence of interference and 10 being severe interference. The sub scale of both sub scores ranges 0-40, with 0 indicating no pain/interference and 40 indicating severe pain/interference. The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12.

Outcome measures

Outcome measures
Measure	Duloxetine, 60 mg Daily n=15 Participants Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Brief Pain Inventory Average pain severity	-1.5 units on a scale Interval -2.3 to -0.7
Brief Pain Inventory Average pain interference	-1.6 units on a scale Interval -2.1 to -1.1

SECONDARY outcome

Timeframe: At each visit

The Short Form McGill Pain Questionnaire is a self-administered questionnaire that measures pain intensity experienced by the patient. Scores on 15 descriptors are rated on an intensity scale of 0-3 (with 0 being no pain to 3 being severe pain), and has an overall score of between 0-45, with 0 being no pain and 45 being worst possible pain. The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12.

Outcome measures

Outcome measures
Measure	Duloxetine, 60 mg Daily n=15 Participants Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Short Form McGill Pain Questionnaire	-2.37 units on a scale Interval -4.27 to -0.47

SECONDARY outcome

Timeframe: At each visit

The Clinical Global Impression Scale is a clinician-rated scale that evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The primary analysis for this outcome was assessed at each visit with a longitudinal repeated-measures random regression analysis assessing the rate of change of the measure during the treatment period. The model for the mean included a term for time (modeled as a continuous variable) and the measure effect was the estimated change in the outcome at week 12.

Outcome measures

Outcome measures
Measure	Duloxetine, 60 mg Daily n=15 Participants Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Clinical Global Impression Scale	-1.7 units on a scale Interval -2.3 to -1.1

SECONDARY outcome

Timeframe: At first visit only

The Hamilton Depression Rating Scale is a clinician-rated scale consisting of 17 questions designed to assess depressive symptoms. Scores of 0-7 are considered normal, 8-16 suggest mild depression, 17-23 moderate depression, and scores over 24 are indicative of severe depression. 52 is the maximum score.

Outcome measures

Outcome measures
Measure	Duloxetine, 60 mg Daily n=15 Participants Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Hamilton Depression Rating Scale	6.7 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: At baseline and week 12

The Hamilton Anxiety Rating Scale is a clinician-administered scale designed to assess the severity of symptoms of anxiety. There are 14 items, scored on a scale of 0 (not present) to 4 (severe). The total score range is 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe. The primary analysis of this scale was an endpoint analysis of the change from baseline.

Outcome measures

Outcome measures
Measure	Duloxetine, 60 mg Daily n=15 Participants Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Hamilton Anxiety Rating Scale	-3.3 units on a scale Interval -6.3 to -0.4

SECONDARY outcome

Timeframe: At baseline and week 12

The Irritable Bowel Syndrome (IBS) Quality of Life Scale is a self-report quality of life measure specific to Irritable Bowel Syndrome that can be used to assess the impact of IBS and its treatment. There are 34 items summed and averaged for a total score between 0-100, with higher scores indicating better IBS specific quality of life. Each item measures one of eight sub scales - dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationships - and is rated on a scale of 1-5 indicating how much the subject agrees with the statement (1 is no agreement, 5 is extreme agreement). The primary analysis of this scale was an endpoint analysis of the change from baseline.

Outcome measures

Outcome measures
Measure	Duloxetine, 60 mg Daily n=15 Participants Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Irritable Bowel Syndrome-Quality of Life Scale	14.8 units on a scale Interval 8.9 to 20.8

SECONDARY outcome

Timeframe: At baseline and week 12

The Sheehan Disability Scale is a brief, 5-item self-report tool that assess functional impairment in work/school, social life, and family life. Scores range from 0-10 in each subset, with 0 being unimpaired and 10 being highly impaired. The primary analysis of this scale was an endpoint analysis of the change from baseline.

Outcome measures

Outcome measures
Measure	Duloxetine, 60 mg Daily n=15 Participants Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Sheehan Disability Scale Work/School	-2.5 units on a scale Interval -4.1 to -1.0
Sheehan Disability Scale Social	-1.8 units on a scale Interval -4.0 to 0.3
Sheehan Disability Scale Family	-2.2 units on a scale Interval -3.6 to -0.8

Adverse Events

Duloxetine, 60 mg Daily

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Duloxetine, 60 mg Daily n=15 participants at risk Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
Gastrointestinal disorders nausea	60.0% 9/15 • Number of events 9
Nervous system disorders insomnia	46.7% 7/15 • Number of events 7
Nervous system disorders sedation	26.7% 4/15 • Number of events 4
Gastrointestinal disorders constipation	40.0% 6/15 • Number of events 6
Reproductive system and breast disorders anorgasmia	13.3% 2/15 • Number of events 2
Nervous system disorders dizziness	13.3% 2/15 • Number of events 2
Skin and subcutaneous tissue disorders dry mouth	13.3% 2/15 • Number of events 2
Skin and subcutaneous tissue disorders night sweats	13.3% 2/15 • Number of events 2
Nervous system disorders tremor	13.3% 2/15 • Number of events 2

Additional Information

Brian Brennan, M.D.

McLean Hospital

Phone: 617-855-2911

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place