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

A Randomised, Double-blind Study in Healthy Volunteers to Compare the Properties and Characteristics of an Investigational Formulation of Lamotrigine With Placebo

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorders
• Intervention / Treatment: Drug: Cherry lamotrigine ODT; Drug: Cherry Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

• Healthy as judged by the responsible physician or designee. No clinically significant abnormality identified on the medical or laboratory evaluation. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the Medical Monitor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
• Volunteer must have a normal sense of taste and smell
• Non-smokers or ex-smokers who have given up smoking for at least 3 months. Subjects currently using oral nicotine replacement therapy will not be recruited for this study.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

• Currently being treated for epilepsy or bipolar disorder
• History of allergic, anaphylactic, hypersensitivity or idiosyncratic reaction(s) to lamotrigine or drugs of a similar type.
• History of sensitivity to any of the following excipients- Mannitol, Crospovidone, Sucralose, Magnesium Stearate, artificial Cherry flavour, Ethylcellulose.
• History of clinically relevant skin rashes.
• History or presence of any medical disorder which in the view of the investigator and GSK Medical Monitor makes the subject unsuitable for the study.
• History of multiple allergies to drugs, chemicals or foods, or a history of a clinically important allergy (e.g. anaphylaxis) to any one substance.
• Currently suffering from perennial rhinitis or seasonal rhinitis, a cold, influenza or any other respiratory illness.
• Has received prescribed or non prescribed medication (including vitamins and herbal remedies) within 7 days prior to the test day which in the opinion of the investigator in consultation if necessary with the GSK Medical Monitor may interfere with the study procedure or compromise safety.
• Currently or recently prescribed any medication which may be affected by lamotrigine including antiepileptics.
• Participation in another sensory analysis study within 30 days preceding the test day.
• Treatment with an investigational drug within 30 days preceding the test day.
• Females with a positive hCG pregnancy test on the test day.
• Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units for men and a weekly intake of greater than14 units or an average daily intake of greater than 2 units for women. [NOTE: 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine]. Subjects must be willing to abstain from alcohol for 24 hours before each visit to the unit for the duration of the study.
• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
• The subject has a positive drug/alcohol screen on the test day. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; To receive the sequence of investigational products in the order of AB where A is cherry lamotrigine ODT and B is cherry placebo.	Drug: Cherry lamotrigine ODT; 25mg, taken orally on one study visit; Drug: Cherry Placebo; Taken orally on one study visit
EXPERIMENTAL: Group 2; To receive the sequence of investigational products in the order of BA where A is cherry lamotrigine ODT and B is cherry placebo.	Drug: Cherry lamotrigine ODT; 25mg, taken orally on one study visit; Drug: Cherry Placebo; Taken orally on one study visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison score of flavor and aftertaste between the active and placebo tablets.	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison score of mouth feel between the active and placebo tablets	1 day

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

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

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 11, 2008
• Primary Completion (ACTUAL): July 18, 2008
• Study Completion (ACTUAL): July 18, 2008

Study Registration Dates

• First Submitted: May 24, 2012
• First Submitted That Met QC Criteria: May 24, 2012
• First Posted (ESTIMATE): May 28, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: placebo; Lamotrigine; characteristics; properties
• Additional Relevant MeSH Terms: Mental Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anticonvulsants; Sodium Channel Blockers; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Lamotrigine
• Other Study ID Numbers: 111649

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Clinical Study Report
   Information identifier: 111649
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Annotated Case Report Form
   Information identifier: 111649
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 111649
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 111649
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 111649
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Dataset Specification
   Information identifier: 111649
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Study Protocol
   Information identifier: 111649
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register