Trial Outcomes & Findings for An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder (NCT NCT00961298)
NCT ID: NCT00961298
Last Updated: 2014-07-09
Results Overview
The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale. The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 "very much improved", 4 "no change", and 7 "very much worse."
COMPLETED
PHASE4
17 participants
endpoint [12 weeks]
2014-07-09
Participant Flow
Subjects were referred by a gastroenterologist who had Irritable Bowel Syndrome and anxiety.
Two participants were considered screen failures and were not entered into the placebo run in phase.
Participant milestones
| Measure |
Treatment Arm
Every study eligible subject entered a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
|
|---|---|
|
Two Week Placebo Run in
STARTED
|
15
|
|
Two Week Placebo Run in
COMPLETED
|
14
|
|
Two Week Placebo Run in
NOT COMPLETED
|
1
|
|
12 Weeks Duloxetine Treatment Phase
STARTED
|
14
|
|
12 Weeks Duloxetine Treatment Phase
COMPLETED
|
11
|
|
12 Weeks Duloxetine Treatment Phase
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment Arm
Every study eligible subject entered a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
|
|---|---|
|
Two Week Placebo Run in
Withdrawal by Subject
|
1
|
|
12 Weeks Duloxetine Treatment Phase
Withdrawal by Subject
|
2
|
|
12 Weeks Duloxetine Treatment Phase
Protocol Violation
|
1
|
Baseline Characteristics
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=15 Participants
every subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
|
|---|---|
|
Age, Continuous
|
42.54 years
STANDARD_DEVIATION 12.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: endpoint [12 weeks]Population: per protocol
The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale. The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 "very much improved", 4 "no change", and 7 "very much worse."
Outcome measures
| Measure |
Treatment Arm
n=11 Participants
every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
|
|---|---|
|
Clinical Global Impression Scale
|
2.64 scores on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: endpoint [12 weeks]The HAM-A is a 14 question scale with five responses. Responses range from 0 "not present" to 4 "very severe." The total score ranges from 0 to 56. Higher values represent a worse outcome.
Outcome measures
| Measure |
Treatment Arm
n=11 Participants
every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
|
|---|---|
|
Hamilton Anxiety Rating Scale
|
9.75 scores on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: endpoint [12 weeks]The IBS-QOL consists of 34 items, each with a five-point response scale. Ratings range from 1 "not at all" to 5 "extremely" or "a great deal" Higher responses on the scale indicate worse outcome. A minimal total score would be 34, maximum 170.
Outcome measures
| Measure |
Treatment Arm
n=11 Participants
every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
|
|---|---|
|
Irritable Bowel Syndrome-Quality of Life Scale
|
81.73 scores on a scale
Standard Deviation 19.25
|
SECONDARY outcome
Timeframe: endpoint [12 weeks]This is a 4 item Likert scale with each assessment being 100 mm scored from measuring from 0 to 400. Higher numbers indicate worse outcome.
Outcome measures
| Measure |
Treatment Arm
n=11 Participants
every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
|
|---|---|
|
Irritable Bowel Syndrome Severity Scoring System
|
187.09 scores on a scale
Standard Deviation 54.05
|
Adverse Events
Treatment Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm
n=15 participants at risk
every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
|
|---|---|
|
Gastrointestinal disorders
constipation
|
20.0%
3/15 • Number of events 3 • within 14 weeks.
patient interview at study visit.
|
|
Gastrointestinal disorders
nausea
|
33.3%
5/15 • Number of events 5 • within 14 weeks.
patient interview at study visit.
|
|
General disorders
fatigue
|
33.3%
5/15 • Number of events 5 • within 14 weeks.
patient interview at study visit.
|
|
Gastrointestinal disorders
dry mouth
|
6.7%
1/15 • Number of events 1 • within 14 weeks.
patient interview at study visit.
|
|
Psychiatric disorders
anxiety
|
6.7%
1/15 • Number of events 1 • within 14 weeks.
patient interview at study visit.
|
|
Nervous system disorders
dizziness
|
20.0%
3/15 • Number of events 3 • within 14 weeks.
patient interview at study visit.
|
|
Endocrine disorders
weight gain
|
6.7%
1/15 • Number of events 1 • within 14 weeks.
patient interview at study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place