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

NCT01607086 | Completed Phase 1

• 1 other identifier: 111649
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Disorders

Keywords

Lamotrigine; placebo; properties; characteristics

Outcome Measures

Primary Outcomes (1)

• Comparison score of flavor and aftertaste between the active and placebo tablets.

  1 day

Secondary Outcomes (1)

• Comparison score of mouth feel between the active and placebo tablets

  1 day

Study Arms (2)

Group 1

EXPERIMENTAL

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; Drug: Cherry Placebo

Group 2

EXPERIMENTAL

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; Drug: Cherry Placebo

Interventions

Cherry lamotrigine ODT DRUG

25mg, taken orally on one study visit

Group 1; Group 2

Cherry Placebo DRUG

Taken orally on one study visit

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Publications (1)

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

  BACKGROUND

Related Links

• Results for study 111649 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 28, 2012
• Study Start: July 11, 2008
• Primary Completion: July 18, 2008
• Study Completion: July 18, 2008
• Last Updated: August 3, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)