Investigating the acceptability of a single dose of Strepsils Strawberry sugar free and Orange colour free with Vitamin C lozenges in children
| ISRCTN | ISRCTN34958871 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34958871 |
| Secondary identifying numbers | TH1016 |
- Submission date
- 30/08/2012
- Registration date
- 05/09/2012
- Last edited
- 29/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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
Emma.Field@ReckittBenckiser.com
Contact information
Scientific
Hill House
4A Bye Street
Ledbury
HR8 2AA
United Kingdom
Study information
| Study design | Open label single dose taste test |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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(s) | Reading Independent Ethics Committee |
| Condition | Healthy subjects |
| Intervention | AMC 0.5mg and DCBA 1.2mg sore throat lozenge |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 17/11/2010 |
| Overall study end date | 10/12/2010 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 102 |
| Participant inclusion criteria | 1. Aged 6 to 12 years inclusive 2. Male or female 3. Healthy volunteers |
| 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 subjects 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 | 17/11/2010 |
| Recruitment end date | 10/12/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
HR8 2AA
United Kingdom
Sponsor information
Industry
Dansom Lane
Hull
HU8 7DS
United Kingdom
| Website | http://www.rb.com/ |
|---|---|
"ROR" |
https://ror.org/01g87hr29 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No |
