Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In 2006, the European Agency for the Evaluation of Medicinal Products (EMEA) stated that the main consideration when developing medications for children should be its acceptability to the child. It described the difficulty experienced by children in recognising tastes and suggested that their ability to recognise flavour may also be affected by the concentration of the flavour and the appearance of the medication. The purpose of this taste testing study is to investigate the acceptability of the flavours of Strepsils strawberry sugar free and orange colour free with vitamin C in children aged six to twelve years old.

Who can participate?
Healthy, male and female children aged between 6 and 12 years.

What does the study involve?
Participants will receive a single Strepsils strawberry sugar free lozenge followed at least 15 minutes later by a single Strepsils orange colour free with vitamin C lozenge. All participants will taste the strawberry flavoured lozenge first, followed by the orange flavoured lozenge. Each participant will suck the lozenge for 1 minute and will be instructed not to chew, crunch or swallow the lozenge and to spit it out after 1 minute. After this they will be asked a series of questions on a questionnaire.

What are the possible benefits and risks of participating?
There is no anticipated benefit for the participants. The safety of Strepsils lozenges has been well established over many years of use as an over the counter product and the potential risks to subjects are considered to be low.

Where is the study run from?
Aspect Clinical, Ledbury.

When is the study starting and how long is it expected to run for?
The study ran from November to December 2010.

Who is funding the study?
Reckitt Benckiser, UK.

Who is the main contact?
Emma Field

Trial website

Contact information



Primary contact

Dr Alex Thompson


Contact details

Hill House
4A Bye Street
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

An open label taste testing study in healthy children to investigate the acceptability of a single dose of Strepsils Strawberry sugar free and Orange colour free with Vitamin C lozenges


Study hypothesis

To assess the taste acceptability in children, aged between 6 and 12 years, of two flavour vairants of an AMC 0.5mg and DCBA 1.2mg sore throat lozenge (strawberry and orange)

Ethics approval

Reading Independent Ethics Committee

Study design

Open label single dose taste test

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Healthy subjects


AMC 0.5mg and DCBA 1.2mg sore throat lozenge

Intervention type



Not Applicable

Drug names

Primary outcome measures

The percentage of children that rated each lozenge above four on the hedonic facial scale.

Secondary outcome measures

Descriptive summary statistics (mean, standard deviation, median, min, max) and the frequencies (with percentages) of the hedonic facial scale scores for each lozenge were presented.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Aged 6 to 12 years inclusive
2. Male or female
3. Healthy volunteers

Participant type

Healthy volunteer

Age group




Target number of participants


Participant exclusion criteria

1. A history of hereditary fructose intolerance
2. A history of sensitivity to an analgesic medication, its ingredients or related products, or any previous history of allergy or known intolerance to dichlorobenzyl alcohol, amylmetacresol, any colouring, flavouring, preservative, sweetener or surfactant. (A list of all constituents that could possibly have given rise to allergy is given in Appendix III of the protocol)
3. A history of hepatic or renal impairment, cardiac disease or high blood pressure
4. A history of asthma
5. A history of peptic or duodenal ulcers, gastro-intestinal bleeding or frequent dyspepsia, e.g. heartburn or indigestion
6. A respiratory infection or any other condition that could have affected subjects’ perception of taste
7. More than two siblings already participating in the trial
8. Previous completion of the study
9. Participation in a taste testing study within three days of the screening visit
10. Participation in a clinical trial involving consumption of an investigational medicinal product within one month of the screening visit
11. Inability in the opinion of the Medical Investigator to comply fully with the study requirements
12. Use of prescription medications within seven days of the taste testing day
13. Use of analgesic or anaesthetic medication on the day of taste testing
14. Consumption of food or drink that was likely to have affected the subject’s ability to taste the product (e.g. highly spiced meals, mint or menthol based products) on the day of taste testing
15. Use of non-prescription medication in the four hours before taste testing
16. Current mouth ulcer
17. Any dental work on the day of taste testing

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Hill House
United Kingdom

Sponsor information


Reckitt Benckiser Healthcare (UK)

Sponsor details

Dansom Lane
United Kingdom

Sponsor type




Funder type


Funder name

Reckitt Benckiser Healthcare (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in:

Publication citations

  1. Results

    Thompson A, Reader S, Field E, Shephard A, Open-label taste-testing study to evaluate the acceptability of both strawberry-flavored and orange-flavored amylmetacresol/2,4-dichlorobenzyl alcohol throat lozenges in healthy children., Drugs R D, 2013, 13, 2, 101-107, doi: 10.1007/s40268-013-0012-x.

Additional files

Editorial Notes