E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Acute inflammation of the back of the throat |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
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 |
To evaluate the short-term efficacy of different MyramistinTM doses
(0.005%, 0.01% and 0.02%) compared to placebo in the symptomatic treatment of acute pharyngitis. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the long-term efficacy, safety and tolerability of different MyramistinTM doses (0.005%, 0.01% and 0.02%) compared to placebo in the symptomatic treatment of acute pharyngitis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male and female at the ages of 18 to 75 years
2. Body Mass Index (BMI): 18-31 kg/m2
3. Willing and able to give informed consent
4. Clinically diagnosed acute pharyngitis
5. Onset of symptoms of acute pharyngitis within the past 48 hours prior to Visit 1
6. Symptoms of acute pharyngitis such as sore throat and difficulty to swallow
7. Sore throat pain intensity scored as at least 60 mm on a 0-100 mm VAS Sore Throat Pain Intensity Scale (STPIS)
8. Difficulty in swallowing of at least 60 mm on a 0-100 mm VAS Difficulty Swallowing Scale (DSS)
9. Tonsillo-Pharyngitis Assessment (TPA) ≥ 6 on 21-point TPA- scale
10. Absence of Streptococcus group A as confirmed by a rapid swab test before randomization
11. Determination of McIsaac - Score (to exclude GAS pharyngitis)
12. Willing to stay in the trial center for at least 2 hours (maximum 3 hrs) after the first dose and return after 72 hours treatment on Day 4
13. Willing not to take anything by mouth excluding the trial medication and / or unable to abstain from smoking during the stay in the trial center. Drinking of water is allowed from 30 minutes after first application onwards.
14. Female patients must have
• either a negative pregnancy test at Visit 1 and practicing a reliable method of contraception used consistently and correctly (including oral contraceptives, hormone implant, intrauterine device), or
• must be postmenopausal (no spontaneous menstrual periods for at least 12 months) or
• must be surgically sterile (tubal ligation or removal of ovaries or uterus)
15. Negative test result for SARS-CoV-2 (COVID) via rapid antigen test |
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E.4 | Principal exclusion criteria |
1. Patients with strong suspicion of Group A Streptococcus infection. Either swab test is positive OR McIsaac Score ≥3 points
2. Presence of signs or symptoms of any acute infection for which treatment with antibiotics is mandatory and/or should not be postponed; i.e. accompanied fever (> 38°C at Visit 1) and/or - if visually identified pharyngeal - presence of seropurulent, purulent, fibro serous or fibrinous exudate from the pharyngeal mucosa
3. Patients with allergies or bronchial asthma who have a history of exacerbations within 30 days prior to trial inclusion
4. The use of any systemic analgesics / local analgesics in the throat area (e.g. Acetyl Salicylic Acid = ASA > 100 mg), during the trial or within 12 hours prior first study medication application. Exception Paracetamol: intake of Paracetamol is allowed up to 6 hours before first application of study medication
5. The use of systemic antibiotics / local antibiotics in the throat area during the trial and within the previous 7 days prior to Visit 1
6. The use of any systemic or local (i.e. in the throat area) antihistamines started within 2 weeks prior to Visit 1
7. The use of any systemic anti-inflammatory drug / local anti-inflammatory drug in the throat area (e.g. non-steroidal anti-inflammatory drugs or glucocorticoids) during the trial or within 12 hours prior first study medication application
8. The use of local anaesthetics for treatment of sore throat during the trial or within 12 hours prior to first study medication application.
9. The use of any other ‘sore throat medication’ (e.g. lozenges, drops, sprays, decongestants) or other ‘cold medication’ that could interfere the trial results within the previous 12 hours prior to first study medication application
10. Major wounds of the mouth and throat
11. Immunodeficiency disorders (e.g. organ transplantation, HIV infection)
12. Existing cardiac, haematological, hepatic, renal, gastrointestinal, metabolic and / or pathological findings, which might interfere with the drug’s safety, tolerability and / or absorption according to the judgement of the Investigator
13. Any neurological or psychiatric conditions, which might give the impression that the patients will not comply with the protocol and trial needs
14. Patients with history (previous 5 years) or present condition of any malignancy
15. Known hypersensitivity to any ingredient of MyramistinTM and/or any contraindication against the rescue medication Paracetamol
16. Previous participation in the trial
17. Parallel participation in any other trial with an IMP during the previous 90 days before screening
18. History of alcohol or drug abuse
19. Known or suspected of being unable to comply with the clinical trial protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
20. Legal incapacity and / or other circumstances rendering the patients unable to understand the nature, scope and possible impact of the trial
21. Female patients meeting any of the following criteria will not be eligible:
- Pregnant
- Lactating
22. Patients who are members of the staff of the trial centre, staff of the Sponsor or the clinical research organisations (CROs), the Investigator him-/ herself or close relatives of the Investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
• The primary endpoint is SPID-2Pain, defined as pain intensity
differences (PID) summarized over the time course of 2 hours after first application on Day 1 (Baseline). The sum is calculated over the timeweighted differences from each measured time point to Baseline after dosing using the 100mmVAS Sore Throat Pain Intensity Scale (STPIS) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
timepoints summarized over the time course of 2 hours (10, 15, 20, 30, 45, 60, 75, 90, 105, and 120 mins) |
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E.5.2 | Secondary end point(s) |
• SPID-2Swallow calculated analogously to the primary endpoint (including sensitivity analysis) using the Difficulty Swallowing Scale (DSS)
• Over 1 Hour: SPID-1Pain and SPID-1Swallow analogously to SPID-2
• Over 3 Hours: SPID-3Pain and SPID-3Swallow analogously to SPID-2
• Throat Pain Intensity (PI) and Pain Intensity Differences from baseline (PID) separately for throat pain and difficulty in swallowing at each measured time point (after 10, 15, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, and 180 minutes).
• Time to 30% and 50% pain relief (30% and 50% reduction in STPIS) compared to baseline
• Time to 30% and 50% relief in difficulty in swallowing (30% and 50% reduction in DSS) compared to baseline
• PI and PID for STPIS and DSS for Day 1 (evening rating), Day 2 and Day 3 (morning and evening rating) and Day 4 (morning rating)
• Percentage of patients symptom free in throat pain at Visit 2 (STPIS=0).
• Percentage of patients symptom free in difficulty in swallowing at Visit 2 (DSS=0)
• Percentage of patients symptom free in throat pain and difficulty in swallowing at Visit 2 (STPIS=0 and DSS=0 – defined as complete response)
• Change in Tonsillo-Pharyngitis Assessment (TPA) sum-score and single symptom scores from baseline to Visit 2
• Global assessment of efficacy by patient and by Investigator
• Percentage of patients requiring further medication (including rescue medication, see section 9.3) for treatment of acute pharyngitis during the clinical trial
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
several timepoints depending on several endpoints |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
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 | No |
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
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LSLV (Last patient last visit) |
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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 | 16 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 16 |