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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00579982 |
Purpose
To determine the convenience and satisfaction of new orally disintegrating tablet formulation (ODT) of lamictal in subjects with a mood disorder. This was a multicenter, open-label study in participants with a mood disorder, who reported difficulty or discomfort in swallowing the currently marketed IR compressed tablet formulation of lamotrigine and who had a person (such as a spouse, partner, companion, aid, nurse, caregiver, etc) willing to complete a Companion/Caregiver Question. Subjects were switched from the currently marketed lamotrigine IR formulation to a matching dose of lamotrigine IR orally disintegrating tablet (ODT) for 3 weeks to determine convenience and satisfaction.
| Condition | Intervention | Phase |
|---|---|---|
|
Mood Disorders Mood Disorder |
Drug: Lamotrigine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Trial Measuring Satisfaction and Convenience of Two Formulations of Lamotrigine in Subjects With a Mood Disorder |
| Enrollment: | 97 |
| Study Start Date: | January 2008 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Lamotrigine
Experimental formulation
Other Name: Lamotrigine
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If female, the subject is eligible to enter and participate in this study if she is not lactating and is of:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| GSK Investigational Site | |
| San Diego, California, United States, 92108 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Fairview Heights, Illinois, United States, 62208 | |
| United States, Minnesota | |
| GSK Investigational Site | |
| Minneapolis, Minnesota, United States, 55454 | |
| United States, Missouri | |
| GSK Investigational Site | |
| St. Charles, Missouri, United States, 63301 | |
| United States, New York | |
| GSK Investigational Site | |
| Olean, New York, United States, 14760 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Cincinnati, Ohio, United States, 45243 | |
| GSK Investigational Site | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Texas | |
| GSK Investigational Site | |
| Arlington, Texas, United States, 76012 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77042 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77014 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Norfolk, Virginia, United States, 23505 | |
| United States, West Virginia | |
| GSK Investigational Site | |
| Charleston, West Virginia, United States, 25301 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00579982 History of Changes |
| Other Study ID Numbers: | LBI108884 |
| Study First Received: | December 20, 2007 |
| Results First Received: | June 4, 2009 |
| Last Updated: | February 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Mood disorder |
|
Mood Disorders Mental Disorders Lamotrigine Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Anticonvulsants Central Nervous System Agents |