Trials / Completed
CompletedNCT00579982
An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder
An Open-Label Trial Measuring Satisfaction and Convenience of Two Formulations of Lamotrigine in Subjects With a Mood Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 97 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lamotrigine | Experimental formulation |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2008-02-01
- Completion
- 2008-02-01
- First posted
- 2007-12-24
- Last updated
- 2016-12-16
- Results posted
- 2009-08-03
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00579982. Inclusion in this directory is not an endorsement.