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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01607086
First received: May 24, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Mental Disorders
Drug: Cherry lamotrigine ODT
Drug: Cherry Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind Study in Healthy Volunteers to Compare the Properties and Characteristics of an Investigational Formulation of Lamotrigine With Placebo

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Comparison score of flavor and aftertaste between the active and placebo tablets. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison score of mouth feel between the active and placebo tablets [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607086

Locations
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01607086     History of Changes
Other Study ID Numbers: 111649
Study First Received: May 24, 2012
Last Updated: May 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Lamotrigine
placebo
properties
characteristics

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Anticonvulsants
Lamotrigine
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 27, 2014