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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alicia Kaplan, West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00961298
First received: August 17, 2009
Last updated: June 8, 2014
Last verified: June 2014
Results First Received: March 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Irritable Bowel Syndrome
Generalized Anxiety Disorder
Intervention: Drug: Duloxetine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were referred by a gastroenterologist who had Irritable Bowel Syndrome and anxiety.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two participants were considered screen failures and were not entered into the placebo run in phase.

Reporting Groups
  Description
Treatment Arm Every study eligible subject entered a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.

Participant Flow for 2 periods

Period 1:   Two Week Placebo Run in
    Treatment Arm
STARTED   15 
COMPLETED   14 
NOT COMPLETED   1 
Withdrawal by Subject                1 

Period 2:   12 Weeks Duloxetine Treatment Phase
    Treatment Arm
STARTED   14 
COMPLETED   11 
NOT COMPLETED   3 
Withdrawal by Subject                2 
Protocol Violation                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment Arm every subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.

Baseline Measures
   Treatment Arm 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.54  (12.70) 
Gender 
[Units: Participants]
 
Female   13 
Male   2 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   15 
More than one race   0 
Unknown or Not Reported   0 


  Outcome Measures
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1.  Primary:   Clinical Global Impression Scale   [ Time Frame: endpoint [12 weeks] ]

2.  Secondary:   Hamilton Anxiety Rating Scale   [ Time Frame: endpoint [12 weeks] ]

3.  Secondary:   Irritable Bowel Syndrome-Quality of Life Scale   [ Time Frame: endpoint [12 weeks] ]

4.  Secondary:   Irritable Bowel Syndrome Severity Scoring System   [ Time Frame: endpoint [12 weeks] ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alicia Kaplan MD
Organization: Allegheny General Hospital
phone: 412-330-4069
e-mail: akaplan@wpahs.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alicia Kaplan, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT00961298     History of Changes
Other Study ID Numbers: RC-4656
Study First Received: August 17, 2009
Results First Received: March 14, 2014
Last Updated: June 8, 2014
Health Authority: United States: Institutional Review Board