Sore throat MedDRA version: 12.1 Level: LLT Classification code 10041367 Term: Sore throat
Conditions
Interventions
Product Name: 0.6mg AMC 1.2mg DCBA Mouth-Watering Lozenge
Pharmaceutical Form: Lozenge
INN or Proposed INN: AMYLMETACRESOL
CAS Number: 1300943
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Reckitt Benckiser Healthcare (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only patients to whom all of the following conditions apply will be included: 1) Age: = 16 to = 75. 2) Both male and female patients may be included. 3) Primary diagnosis: Patients with dry and irritated sore throat of onset within the past 4 days (i.e. = 4 days) due to URTI or environmental factors. 4) Objective findings that confirm the presence of tonsillopharyngitis (= 3 points on the expanded 21-point Tonsillopharyngitis Assessment). 5) 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'). 6) Patients who have a dry throat (= 3) on the throat dryness scale at baseline. They will be instructed by the study nurse to swallow and circle the number on the scale that shows how your dry/moist your throat is when you swallow. Ratings on this 0-10 ordinal scale will be marked with 0= completely dry (besides ‘0’ rating) and 10= completely moist (beside ’10). 7) Patients who have a scratchy, tickly or itchy throat (= 5) on the throat irritation scale at baseline. They will be instructed by the study nurse to swallow and circle the number on the scale that shows how scratchy, tickly or itchy your throat is when you swallow. Ratings on this 0-10 ordinal scale will be marked with 0= completely scratchy, tickly or itchy (besides ‘0’ rating) and 10= not at all scratchy, tickly or itchy (beside ’10). 8) Patients who have given written informed consent. Are the trial subjects under 18? yes 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 constituents, AMC, DCBA, tartaric acid, isomalt, maltitol, water, flavourings, sweeteners (acesulfame) and colourings (copper chlorophyllin). 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 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.). 15) Those unable to refrain from smoking during their stay in the investigative site. 16) Women of childbearing potential , who report they 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). Adequate contraception should also include abstinence, barrier contraception and partner vasectomy. A woman of child bearing 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). 17) Those previously randomised into the study. 18) 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. 19) 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 |
|---|---|
| Secondary Objective: The secondary objective of this study is to determine consumer acceptability of the product via responses to a consumer questionnaire (Appendix III).;Primary end point(s): The primary efficacy endpoint for this study is 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 a new Strepsils lozenge in patients with a dry and irritated sore throat due to upper respiratory tract infection (URTI) or environmental factors. The analgesic properties will be assessed by comparing sore throat relief and throat soreness in patients treated with the Strepsils lozenge and patients treated with a placebo lozenge. In addition to the analgesic endpoints, functional measures of throat dryness and throat irritation will also be assessed. | — |
Countries
United Kingdom
Outcome results
None listed