Sore throat MedDRA version: 9.1 Level: LLT Classification code 10041367 Term: Sore throat
Conditions
Interventions
Trade Name: Strepsils Original
Product Name: Strepsils Original
Pharmaceutical Form: Lozenge
INN or Proposed INN: AMYLMETACRESOL
CAS Number: 1300943
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Reckitt Benckiser Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only patients to whom all of the following conditions apply will be included: 1) Age: 18 - =75; 2) Both male and female patients may be included; 3) Primary diagnosis: Patients with sore throat of onset within the past 4 days (i.e. =4 days) due to upper respiratory tract infection (URTI); 4) Patients who have a sore throat (equal to or more than 6) on the Throat Soreness Scale at baseline. They will be instructed by the study nurse to swallow and ‘Circle the number on the scale that shows how sore your throat is when you swallow’. Ratings on this 0-to-10 ordinal scale will be marked with ‘0 = Not Sore’ (besides the ‘0’ rating) and ’10 = Very Sore’ (beside ’10’). 5) Objective findings that confirm the presence of tonsillopharyngistis (equal to or more than 5 points on the expanded Tonsillopharyngitis Assessment). 6) Patients who have given written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients to whom any of the following conditions apply must be excluded: 1. Any previous history of allergy or known intolerance to the study drug or the following formulation constituents, AMC/DCBA, anise oil, peppermint oil, menthol natural or menthol synthetic, tartaric acid gran 571 GDE, ponceau 4R edicol E124, carmoisine edicol E122, sugar, glucose. 2. Any previous history of allergy or known intolerance to the study rescue drug (paracetamol) or the following formulation constituents, maize starch, potassium sorbate, purified talc, stearic acid, polvidone, starch pre-gelatinised, hyromellose, triacetin, ethanol, propylene glycol, shellac, brilliant blue FCF (E133), sodium lactate, dimethylpolysiloxane. 3. Those whose sore throat has been present for more than 4 days. 4. Those who have evidence of mouth breathing. 5. Those who have evidence of severe coughing. 6. Those who have any disease that can compromise breathing e.g. bronchopneumonia. 7. Those who have taken any medicated confectionary, throat pastille, spray, or any products with demulcent properties such as boiled sweets, within the previous 2 hours. 8. Those who have used any sore throat medication containing a local anaesthetic within the past 4 hours. 9. Those who have used any analgesic, antipyretic or ‘cold’ medication (e.g. decongestant, antihistamine, antitussive, or throat lozenge) within the previous 8 hours. 10. Those who have used a longer acting or slow release analgesic during the previous 24 hours e.g. proxicam. 11. Thise taking antibiotics during the previous 14 days. 12. Those with any painful condition that may distract attention from sore throat pain e.g. mouth ulcers, etc. 13. Those with a history of severe renal impairment. 14. Those with a history of severe hepatic impairment. 15. Those taking warfarin and other coumarins. 16. Those taking carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes in the 14 days before enrolment into the study (i.e. before first dosing day). 17. Those with a history of alcohol abuse or regularly consumes alcohol in excess of the recommended amounts (excessive alcohol: >21 units per week for females and >28 units per week for males). 18. Those who are glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia. 19. Those with any painful condition that requires regular analgesic useage. 20. Those unable to refrain from smoking during their stay in the investigative site. 21. Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone an hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy). 22. Those previously randomised into the study. 23. Those who have participated in a clinical trial in the previous 30 days. Thirty days are calculated from time of last dosing in the prior trial to the time of anticipated dosing in this trial. 24. Those unable in the opinion of the Investigator to comply fully with the study requirements, e.g. such as those who cannot comprehend or correctly use the pain rating scales.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the analgesic properties of Strepsils Original lozenges in patients with sore throat due to upper respiratory tract infection (URTI). The analgesic properties will be assessed by comparing throat soreness, sore throat relief in patients treated with Strepsils Original throat lozenges or placebo. In addition to the analgesic endpoints, a functional measure, namely difficulty in swallowing, will also be assessed.;Secondary Objective: The secondary objective of this study is to determine additional patient/consumer benefits associated with Strepsils Original. These benefits will be assessed by measuring freedom from symptoms and also, the responses to a consumer questionnaire, including opinion on pain relief, what the relief feels like e.g. soothing, site of action of the lozenge within the mouth, how fast acting the product is, duration of action, how satisfied the patient is with the pain relief attained and how their sore throat affects their daily activities. ;Primary end point(s): The primary efficacy endpoint for this study is the change from baseline in severity of throat soreness (using the 11 point Throat Soreness Scale) for the Strepsils Original group versus the placebo group at 2 hours post first dose. | — |
Countries
United Kingdom
Outcome results
None listed