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Determination of Absorption and Elimination of Lamotrigine-XR

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ClinicalTrials.gov Identifier: NCT00789113
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Epilepsy
Seizures
Bipolar Disorder
Bipolar Depression
Intervention Drug: Extended Release Lamotrigine
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Extended Release Lamotrigine
Hide Arm/Group Description

Extended Release Lamotrigine

Extended Release Lamotrigine

Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Extended Release Lamotrigine
Hide Arm/Group Description Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Age 65 and older Number Analyzed 12 participants
12
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
7
  58.3%
Male
5
  41.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Area Under the Curve (AUC) for Oral Bioavailability of Lamotrigine (LTG
Hide Description To evaluate the absolute bioavailability of immediate release (IR) and extended release (ER) lamotrigine (LTG) via blood and urine sampling for 24 hour period followed by once a day blood sampling for 3 days following initial dose administration.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Release (IR) Lamotrigine Extended Release Lamotrigine
Hide Arm/Group Description:
Study population was on chronic IR lamotrigine therapy and first period of the study was a continuation of standard treatment with IR lamotrigine.
Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
Overall Number of Participants Analyzed 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg*h/mL
142.8
(92.4 to 220.7)
132.3
(88.1 to 198.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Extended Release Lamotrigine
Hide Arm/Group Description Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
All-Cause Mortality
Extended Release Lamotrigine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Extended Release Lamotrigine
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Extended Release Lamotrigine
Affected / at Risk (%)
Total   0/12 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Rory P. Remmel
Organization: University of Minnesota College of Pharmacy
Phone: 6126240472
EMail: remme001@umn.edu
Layout table for additonal information
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 )
First Submitted: November 7, 2008
First Posted: November 11, 2008
Results First Submitted: January 29, 2015
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016