| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Sore throat due to upper respiratory tract infection |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 12.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10041367 |
| E.1.2 | Term | sore throat |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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 |
|
| E.2.2 | Secondary objectives of the trial |
| 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? |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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
|
|
| E.4 | Principal 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.
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|
| E.5 End points |
| E.5.1 | 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. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The end of the study will be defined as the last follow up telephone call of the last patient undergoing the study. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 4 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 4 |
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