Investigating the acceptability of a single dose of Strepsils Strawberry sugar free and Orange colour free with Vitamin C lozenges in childre

Completed

• Conditions: Not Applicable; Healthy subjects

• Registration Number: ISRCTN34958871
• Lead Sponsor: Reckitt Benckiser Healthcare (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.