A Clinical Trial Investigating the Short-term Relief of Symptoms of Acute Pharyngitis by Treatment With Three Different Doses of MYRAMISTIN™ Oromucosal Spray

NCT ID: NCT04470089

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-18
• Study Completion Date: 2021-12-31

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.

Conditions

Acute Pharyngitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Myramistin 0.005%

Group Type: EXPERIMENTAL

Myramistin

Intervention Type: DRUG

Oromucosal application

Myramistin 0.01%

Group Type: EXPERIMENTAL

Myramistin

Intervention Type: DRUG

Oromucosal application

Myramistin 0.02%

Group Type: EXPERIMENTAL

Myramistin

Intervention Type: DRUG

Oromucosal application

Placebo

Group Type: PLACEBO_COMPARATOR

Myramistin

Intervention Type: DRUG

Oromucosal application

Interventions

Myramistin

Oromucosal application

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Megainpharm GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

KAR

Vienna, , Austria

MUW

Vienna, , Austria

Zentrum für Klinische Studien

Vienna, , Austria

Practive

Berlin, , Germany

Practice

Cologne, , Germany

Practice

Duisburg, , Germany

Practice

Fulda, , Germany

Practice

Goch, , Germany

Practice

München, , Germany

Practice

Neuenhagen, , Germany

Practice

Rosenheim, , Germany

Practice

Wuppertal, , Germany

Countries

Austria; Germany

Other Identifiers

MIRA1

Identifier Type: -

Identifier Source: org_study_id