EUCTR2018-002543-28-AT进行中（未招募）1 期
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 - MIRA 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •Are the trial subjects under 18? no
- •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
排除标准
- •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
研究者
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