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An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00961298
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : July 9, 2014
Last Update Posted : July 9, 2014
Sponsor:
Information provided by (Responsible Party):
Alicia Kaplan, West Penn Allegheny Health System

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Irritable Bowel Syndrome
Generalized Anxiety Disorder
Intervention Drug: Duloxetine
Enrollment 17
Recruitment Details Subjects were referred by a gastroenterologist who had Irritable Bowel Syndrome and anxiety.
Pre-assignment Details Two participants were considered screen failures and were not entered into the placebo run in phase.
Arm/Group Title Treatment Arm
Hide Arm/Group Description Every study eligible subject entered a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
Period Title: Two Week Placebo Run in
Started 15
Completed 14
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Period Title: 12 Weeks Duloxetine Treatment Phase
Started 14
Completed 11
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Protocol Violation             1
Arm/Group Title Treatment Arm
Hide Arm/Group Description every subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
42.54  (12.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
13
  86.7%
Male
2
  13.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
15
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Clinical Global Impression Scale
Hide Description

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."

Time Frame endpoint [12 weeks]
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.64  (0.5)
2.Secondary Outcome
Title Hamilton Anxiety Rating Scale
Hide Description 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.
Time Frame endpoint [12 weeks]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
9.75  (4.5)
3.Secondary Outcome
Title Irritable Bowel Syndrome-Quality of Life Scale
Hide Description 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.
Time Frame endpoint [12 weeks]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
81.73  (19.25)
4.Secondary Outcome
Title Irritable Bowel Syndrome Severity Scoring System
Hide Description 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.
Time Frame endpoint [12 weeks]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
187.09  (54.05)
Time Frame within 14 weeks.
Adverse Event Reporting Description patient interview at study visit.
 
Arm/Group Title Treatment Arm
Hide Arm/Group Description every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
All-Cause Mortality
Treatment Arm
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Treatment Arm
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Arm
Affected / at Risk (%) # Events
Total   9/15 (60.00%)    
Endocrine disorders   
weight gain * 1  1/15 (6.67%)  1
Gastrointestinal disorders   
constipation * 1  3/15 (20.00%)  3
nausea * 1  5/15 (33.33%)  5
dry mouth * 1  1/15 (6.67%)  1
General disorders   
fatigue * 1  5/15 (33.33%)  5
Nervous system disorders   
dizziness * 1  3/15 (20.00%)  3
Psychiatric disorders   
anxiety * 1  1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, other
A limitation of this pilot study was its small sample size and open label design. Another limitation may be that the patient sample is not representative of a true cross section of the GAD population as a whole.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alicia Kaplan MD
Organization: Allegheny General Hospital
Phone: 412-330-4069
EMail: akaplan@wpahs.org
Layout table for additonal information
Responsible Party: Alicia Kaplan, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT00961298    
Other Study ID Numbers: RC-4656
First Submitted: August 17, 2009
First Posted: August 18, 2009
Results First Submitted: March 14, 2014
Results First Posted: July 9, 2014
Last Update Posted: July 9, 2014