Sore throat due to upper respiratory tract infection MedDRA version: 12.1 Level: LLT Classification code 10041367 Term: sore throat
Conditions
Interventions
Trade Name: Strepsils Plus
Product Name: Strepsils Plus(0.6mg AMC, 1.2mg DCBA- R02AA03 covers both ingredients),10mg Lidocaine
Pharmaceutical Form: Lozenge
INN or Proposed INN: Amylmetacresol BP (A
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 to = 75 years 2) Sex: male and female 3) Primary diagnosis: Sore throat onset within the previous 4 days as a result of a upper respiratory tract infection (URTI) 4) Patients who have a sore throat (= 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 your sore throat is when you swallow. Ratings on this 0-10 ordinal scale will be marked with 0= Not score (besides ‘0’ rating) and 10=Very Sore (beside ’10). 5) At least 1 symptom of URTI on the URTI questionnaire (e.g. sore throat) 6) Objective findings that confirm the presence of tonsillopharyngitis (= 5 points on the expanded 21-point Tonsillopharyngitis Assessment). 7) Patients who have difficulty swallowing score of >50mm on the Difficulty Swallowing Scale at baseline. They will be instructed by the study nurse to swallow and mark a line on the scale that shows how difficult it is for you to swallow. Ratings on this 0-100mm visual analogue scale will be marked with 0= Not Difficult (besides ‘0’ rating) and 100=Very Difficult (beside ’10). 8) Patients who have a swollen throat score of >33mm on the Swollen Throat Scale at baseline. They will be instructed by the study nurse to swallow and mark a line on the scale that shows how swollen their throat feels. Ratings on this 0-100mm visual analogue scale will be marked with 0= Not Swollen (besides ‘0’ rating) and 100=Very Swollen (beside ’10). 9) The patient is willing to take ‘nil by mouth’ 10 minutes before the dose 10) 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 formulation active ingredients (AMC, DCBA, hexylresorcinol or lidocaine) 2) 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, abstinence [should the patient become sexually active, she must agree to use a double barrier method] or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy). 3) Those whose sore throat has been present for more than 4 days. 4) Those who have used any sore throat medication containing a local anaesthetic with in the past 4 hours. 5) Those who have any disease that can compromise breathing e.g. asthma, bronchospasm, bronchopneumonia. 6) The patient has any evidence of mouth-breathing. 7) Those who have evidence of severe coughing. 8) Those who cannot tolerate fructose. 9) Those with a painful condition that may distract attention from sore throat pain (e.g. mouth ulcers, cough). 10) Those with a history of alcohol abuse or consume alcohol in excess of the recommended amounts (excessive alcohol >21 units per week for females and >28 units per week for males). 11) Those who have used an analgesic, antipyretic or cold medication (e.g. decongestant, antihistamine, antitussive or throat lozenge/spray) within the previous 8 hours. 12) Those who have used a longer acting or slow release analgesic during the previous 24 hours e.g. Piroxicam and Naproxen. 13) Those who have taken any medicated confectionary, throat pastille, spray, or any product with demulcent properties such as boiled sweets in the previous 2 hours. 14) Those with any history of renal or hepatic dysfunction. 15) Those previously randomised into the study. 16) 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 time of anticipated dosing in this trial. 17) Those unable in the opinion of the Investigator to comply fully with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of the study is to determine the pain relieving effectiveness of two Strepsils products (Strepsils Plus and Strepsils Extra) in patients with a sore throat due to upper respiratory tract infection (URTI) compared to a placebo (dummy Pill) sugar based lozenge. Strepsils plus contain the same active antiseptic ingredients in Strepsils (0.6mg Amylmetacresol BP (AMC) and 1.2,g 2,4-Dichlorobenzyl alcohol (DCBA)) plus 10mg Lidocaine Hydrochloride which is a well established local anaesthetic characterised by a rapid onset of action and intermediate duration. Strepsils Extra contain 2.4 mg Hexylresorcinol which is an antiseptic with local anaethetic effects;Secondary Objective: The secondary objective of this study is to determine additional patient/consumer benefits with taking the lozenges by looking at patient responses to questionnaires including assessing their feedback on pain relief such as - is it soothing or numbing? did it provide relief from the sore throat? how long did the lozenge provide relief of your sore throat?;Primary end point(s): The primary outcome measure of the study is the change from baseline in the rating of throat soreness (using the 11 point throat soreness scale) for the Strepsils Plus and Extra versus the placebo at the 2 hours post dose. | — |
Countries
United Kingdom
Outcome results
None listed