Effects of Gastric Bypass on Blood Levels of Duloxetine

This study has been completed.
Sponsor:
Collaborators:
University of North Dakota
Eli Lilly and Company
Information provided by (Responsible Party):
James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier:
NCT00989157
First received: October 1, 2009
Last updated: July 17, 2014
Last verified: July 2014
Results First Received: April 8, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Bariatric Surgery
Intervention: Drug: Duloxetine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided


Responsible Party: James Roerig, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier: NCT00989157     History of Changes
Other Study ID Numbers: F1J-US-X054
Study First Received: October 1, 2009
Results First Received: April 8, 2014
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board