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NCT00579982 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder
A Phase 3 study of Mood Disorders, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 97
- Enrollment target
- 18
- Study locations
NCT00579982: Completed Phase 3 study of Mood Disorders, sponsored by GlaxoSmithKline.
NCT00579982 is a Phase 3 study of Mood Disorders that has completed, run by GlaxoSmithKline. The registered enrollment target is 97 participants, below the 935-participant average among 39 other Mood Disorders trials with a reported enrollment target (90% lower). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00579982, a Phase 3 study of Mood Disorders, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 97 participants
- Enrollment target
- 18
- Study locations
Study Summary
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.
Primary Outcome
The CSS is the sum of items 9 (values: 1=Extremely difficult - 7=Extremely easy), 10 (same set of values as for 9), and 11 (1=Extremely inconvenient - 7=Extremely convenient). The sum has 3 subtracted from it, is divided by 18, and then multiplied by 100; the range is 0-100. Change from baseline=end of study CSS minus baseline score.
Conditions Studied
Interventions
- DRUG Lamotrigine
Study Locations (18)
Florida
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Orange City
- GSK Investigational Site - Winter Park
Texas
- GSK Investigational Site - Arlington
- GSK Investigational Site - Houston
- GSK Investigational Site - Houston
California
- GSK Investigational Site - San Diego
- GSK Investigational Site - Santa Ana
Ohio
- GSK Investigational Site - Cincinnati
- GSK Investigational Site - Cleveland
Georgia
- GSK Investigational Site - Marietta
Illinois
- GSK Investigational Site - Fairview Heights
Minnesota
- GSK Investigational Site - Minneapolis
Missouri
- GSK Investigational Site - Saint Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2008-01 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
What the finished NCT00579982 record still lists
NCT00579982 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 935-participant average among 39 other Mood Disorders trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Mood Disorders appearing as the primary indexed condition, and to 1 intervention - of which Lamotrigine is the first listed.
NCT00579982 lists 18 locations in 12 states (Florida, Texas, California).
Frequently Asked Questions
What is clinical trial NCT00579982 about?
NCT00579982 is a clinical study titled "An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder". 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 ...
What is the current status of trial NCT00579982?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 97 participants. The study started on 2008-01. Estimated completion is 2008-02.
What conditions does trial NCT00579982 study?
This clinical trial studies the following conditions: Mood Disorders.
What interventions are being tested in trial NCT00579982?
The interventions under investigation include: Lamotrigine (DRUG).
Who is sponsoring clinical trial NCT00579982?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00579982 being conducted?
This trial has 18 study locations across California, Florida, Georgia, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00579982's enrollment target sits among peer trials
97 28th of 39 higher than 12 of 39 other Mood Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mood Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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