drugset / Trial / NCT01607086

Compare the Properties and Characteristics of an Investigational Formulation of Lamotrigine With Placebo

NCT01607086

Phase 1 Completed 24 enrolled GlaxoSmithKline
RandomizedCrossoverTriple-blindTreatment

Summary

The objective of this sensory analysis study is to determine whether volunteers observe a significant difference in organoleptic properties between lamotrigine (430C78) cherry flavoured orally disintegrating tablets (ODT) and a placebo cherry flavoured orally disintegrating tablet. The aim is to assess the value of the placebo as a marketing aid, whereby physicians and patients may assess the personal acceptability of the organoleptic properties and potential convenience prior to prescription of the ODT formulation.

Timeline

Start
2008-07-11
Primary completion
2008-07-18
Completion
2008-07-18

Publications

  • Background This study has not been published in the scientific literature.

Drugs

EvaluationDrugModalityDoseRoute
Subject Lamotrigine Small molecule 25 mg Oral

Indications