Determination of Absorption and Elimination of Lamotrigine-XR

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00789113
First received: November 7, 2008
Last updated: December 14, 2015
Last verified: December 2015
Results First Received: January 29, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Epilepsy
Seizures
Bipolar Disorder
Bipolar Depression
Intervention: Drug: Extended Release Lamotrigine

  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
Extended Release Lamotrigine

Extended Release Lamotrigine

Extended Release Lamotrigine


Participant Flow:   Overall Study
    Extended Release Lamotrigine  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Extended Release Lamotrigine Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)

Baseline Measures
    Extended Release Lamotrigine  
Number of Participants  
[units: participants]
  12  
Age, Customized  
[units: participants]
 
Age 65 and older     12  
Gender  
[units: participants]
 
Female     7  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures

1.  Primary:   Area Under the Curve (AUC) for Oral Bioavailability of Lamotrigine (LTG   [ Time Frame: 1 week ]


  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. Rory P. Remmel
Organization: University of Minnesota College of Pharmacy
phone: 6126240472
e-mail: remme001@umn.edu


No publications provided


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00789113     History of Changes
Other Study ID Numbers: 0308M51662
IND72642 ( Other Identifier: FDA )
Study First Received: November 7, 2008
Results First Received: January 29, 2015
Last Updated: December 14, 2015
Health Authority: United States: Food and Drug Administration