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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Mental Disorders

Treatments: Drug: Cherry Placebo; Drug: Cherry lamotrigine ODT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01607086

111649

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Group 1

Experimental group

Description:

To receive the sequence of investigational products in the order of AB where A is cherry lamotrigine ODT and B is cherry placebo.

Treatment:

Drug: Cherry Placebo

Drug: Cherry lamotrigine ODT

Group 2

Experimental group

Description:

To receive the sequence of investigational products in the order of BA where A is cherry lamotrigine ODT and B is cherry placebo.

Treatment:

Drug: Cherry Placebo

Drug: Cherry lamotrigine ODT