Last updated: 11/07/2018 03:40:40
Compare the properties and characteristics of an investigational formulation of lamotrigine with placebo
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised, double-blind study in healthy volunteers to compare the properties and characteristics of an investigational formulation of lamotrigine with placebo
Trial description: 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 flavouredorally 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 ODTformulation.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Comparison score of flavor and aftertaste between the active and placebo tablets.
Timeframe: 1 day
Secondary outcomes:
Comparison score of mouth feel between the active and placebo tablets
Timeframe: 1 day
Interventions:
Enrollment:
24
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Mental Disorders
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
July 2008 to July 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion 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:
- 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.
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Trial location(s)
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2008-18-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 111649 can be found on the GSK Clinical Study Register.
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