Clinical trial NCT04470089: A Clinical Trial Investigating the Short-term Relief of Symptoms of Acute Pharyngitis by Treatment With Three Different Doses of MYRAMISTIN™ Oromucosal Spray
Official title: A Multi-center, Randomized, Placebo-controlled, Double-blind, Dose-finding Clinical Trial Investigating the Short-term Relief of Symptoms of Acute Pharyngitis Such as Throat Soreness Pain and Difficulty to Swallow by Treatment With Three Different Doses of MYRAMISTIN™ Oromucosal Spray
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Pharyngitis
Lead sponsor: Megainpharm GmbH
Sponsor class: INDUSTRY
First posted: 2020-07-14
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this multi-center, randomized, placebo-controlled, double-blind stuy in which patients with acute pharyngitis will receive Myramistin™ / Placebo, which is provided as a spray. Patients will be randomised at Visit 1 on a 1:1:1:1 basis to one of the three MyramistinTM doses (0.005%, 0.01% and 0.02%) or placebo. The trial duration for an individual patient is 72 hours.

The primary objective is 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.


Eligibility criteria: 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 (Visual Analogue Scale) 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 Group A Streptococcus as confirmed by a rapid swab test before randomization
11. McIsaac - Score \<3
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 investigational medical product (IMP) and / or unable to abstain from smoking during the stay in the trial center. Drinking of water is allowed.
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 (not spontaneous menstrual periods for at least 6 months) or
    * must be surgically sterile (tubal ligation or removal of ovaries or uterus)

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 IMP
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 to first IMP application
8. The use of local anaesthetics for treatment of sore throat during the trial or within 12 hours prior to first IMP 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
16. Previous participation in the trial
17. Parallel participation in any other trial 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

Primary outcomes:
measure: Pain Intensity Differences
timeFrame: 2 hours
Secondary outcomes:
measure: Pain Intensity Differences
timeFrame: 72+/-2 hours
measure: Difficulty to Swallow Differences
timeFrame: 72+/-2 hours
measure: Time to Pain Relief
timeFrame: 72+/-2 hours
measure: Time to relief in Difficulty to Swallow
timeFrame: 72+/-2 hours
measure: Percentage of symptom free patients
timeFrame: 72+/-2 hours
measure: Tonsillo-Pharyngitis Assessment Scale
timeFrame: 72+/-2 hours
Other outcomes:
measure: Safety Endpoints
timeFrame: 72+/-2 hours
measure: Tolerability Endpoints
timeFrame: 72+/-2 hours
Locations:
city: Wien
country: Austria
facility: KAR
city: Wien
country: Austria
facility: MUW
city: Wien
country: Austria
facility: Zentrum für Klinische Studien
city: Berlin
country: Germany
facility: Practive
city: Duisburg
country: Germany
facility: Practice
city: Fulda
country: Germany
facility: Practice
city: Goch
country: Germany
facility: Practice
city: Köln
country: Germany
facility: Practice
city: München
country: Germany
facility: Practice
city: Neuenhagen
country: Germany
facility: Practice
city: Rosenheim
country: Germany
facility: Practice
city: Wuppertal
country: Germany
facility: Practice
Study officials:
References: