Healthy subjects Not Applicable
Conditions
Interventions
AMC 0.5mg and DCBA 1.2mg sore throat lozenge
Sponsors
Reckitt Benckiser Healthcare (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 6 to 12 years inclusive 2. Male or female 3. Healthy volunteers
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of children that rated each lozenge above four on the hedonic facial scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed