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Effects of Gastric Bypass on Blood Levels of Duloxetine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00989157
First Posted: October 2, 2009
Last Update Posted: August 11, 2014
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.
Collaborators:
University of North Dakota
Eli Lilly and Company
Information provided by (Responsible Party):
James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
Results First Submitted: April 8, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Bariatric Surgery
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control Matched to bariatric subject via BMI, age and gender
Bariatric One year post surgery

Participant Flow:   Overall Study
    Control   Bariatric
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 



  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.
Available Bariatric surgery candidates and pilot study results.

Reporting Groups
  Description
Bariatric Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
Control Subjects matched to the bariatric subjects via BMI, age and gender
Total Total of all reporting groups

Baseline Measures
   Bariatric   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.10  (9.02)   45.9  (8.54)   45  (8.78) 
Gender 
[Units: Participants]
     
Female   9   9   18 
Male   1   1   2 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cmax   [ Time Frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 ]

2.  Primary:   Tmax   [ Time Frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 ]

3.  Primary:   AUCo-inf,   [ Time Frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 ]

4.  Primary:   T1/2   [ Time Frame: 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 ]

5.  Secondary:   Emesis   [ Time Frame: 4 days ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. James Roerig
Organization: NRIFargo
phone: 701 365 4919
e-mail: jroerig@nrifargo.com



Responsible Party: James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier: NCT00989157     History of Changes
Other Study ID Numbers: F1J-US-X054
First Submitted: October 1, 2009
First Posted: October 2, 2009
Results First Submitted: April 8, 2014
Results First Posted: August 11, 2014
Last Update Posted: August 11, 2014