Sore throat MedDRA version: 9.1 Level: LLT Classification code 10041367 Term: Sore throat
Conditions
Interventions
Product Name: 0.6mg AMC lozenge
Product Code: 0172021
Pharmaceutical Form: Lozenge
INN or Proposed INN: AMYLMETACRESOL
CAS Number: 1300943
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Reckitt Benckiser Healthcare UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: =18 to =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) 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) Objective findings that confirm the presence of tonsillopharyngitis (= 5 points on the expanded 21-point 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: 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 and glucose. 2) Those whose sore throat has been present for more than 4 days. 3) Those who have evidence of mouth breathing 4) Those who have evidence of severe coughing 5) Those who have any disease that can compromise breathing e.g. bronchopneumonia. 6) 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. 7) Those who have used any sore throat medication containing a local anaesthetic within the past 4 hours. 8) Those who have used any analgesic, antipyretic or cold medication (e.g. decongestant, antihistamine, antitussive or throat lozenge) within the previous 8 hours. 9) Those who have used a longer acting or slow release analgesic during the previous 24 hours e.g. Piroxicam and Naproxen. 10) Those taking antibiotics during the previous 14 days 11) Those with any painful condition that may distract attention from sore throat pain e.g. mouth ulcers etc. 12) Those with a history of severe renal impairment. 13) Those with a history of severe hepatic impairment 14) Those taking warfarin and other coumarins 15) Those taking carbamezepine, phenobarbitone, phenytoin, primidone, rifampicin, St Johns Wort or other drugs that induce liver enzymes in the 14 days before enrolment into the study (i.e. before first dosing day) 16) Those with a history of alcohol abuse or state that they regularly consume alcohol in excess of the recommended amounts (excessive alcohol >21 units per week for females and >28 units per week for males.) 17) Those who are glutathione-deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia. 18) Those with any painful condition that requires analgesic usage 19) Those unable to refrain from smoking during their stay in the investigative site 20) Women 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 or an intrauterine device. A women of child bearing 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) 21) Those previously randomised into the study 22) 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. 23) 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 |
|---|---|
| Primary end point(s): The area under the change from baseline curve (AUC) in severity of throat soreness from 0 to 2 hours.;Main Objective: The primary objective of this study is to determine the analgesic properties of 0.6 mg AMC only and 1.2 mg DCBA only lozenges in patients with sore throat due to upper respiratory tract infection (URTI). The analgesic properties will be assessed by comparing throat soreness and sore throat relief in patients treated with 0.6 mg AMC only and 1.2 mg DCBA only lozenges with patients treated with placebo. In addition to the analgesic endpoints, functional measures of difficulty in swallowing and throat numbness will also be assessed.;Secondary Objective: The secondary objective of this study is to determine additional patient/consumer benefits associated with 0.6 mg AMC only lozenges and 1.2 mg DCBA only lozenges. These benefits will be assessed by, the responses to a consumer questionnaire, including opinion on pain relief, what the relief feels like, e.g. soothing, numbing, site of action of the lozenge in the mouth, how fast acting the product is, duration of action and how satisfied the patient is with the pain relief attained. | — |
Countries
United Kingdom
Outcome results
None listed