NCT04470089终止2 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 170
- 试验地点
- 5
- 主要终点
- Pain Intensity Differences
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female at the ages of 18 to 75 years
- •Body Mass Index (BMI): 18-31 kg/m2
- •Willing and able to give informed consent
- •Clinically diagnosed acute pharyngitis.
- •Onset of symptoms of acute pharyngitis within the past 48 hours prior to Visit 1
- •Symptoms of acute pharyngitis such as sore throat and difficulty to swallow
- •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)
- •Difficulty in swallowing of at least 60 mm on a 0-100 mm VAS Difficulty Swallowing Scale (DSS)
- •Tonsillo-Pharyngitis Assessment (TPA) ≥ 6 on 21-point TPA- scale
- •Absence of Group A Streptococcus as confirmed by a rapid swab test before randomization
- •McIsaac - Score <3
- •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
- •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.
- •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)
排除标准
- •Patients with strong suspicion of Group A streptococcus infection. Either swab test is positive OR McIsaac Score ≥ 3 points
- •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
- •Patients with allergies or bronchial asthma who have a history of exacerbations within 30 days prior to trial inclusion
- •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
- •The use of systemic antibiotics / local antibiotics in the throat area during the trial and within the previous 7 days prior to Visit 1
- •The use of any systemic or local (i.e. in the throat area) antihistamines started within 2 weeks prior to Visit 1
- •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
- •The use of local anaesthetics for treatment of sore throat during the trial or within 12 hours prior to first IMP application
- •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
- •Major wounds of the mouth and throat
- •Immunodeficiency disorders (e.g. organ transplantation, HIV infection)
- •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
- •Any neurological or psychiatric conditions, which might give the impression that the patients will not comply with the protocol and trial needs
- •Patients with history (previous 5 years) or present condition of any malignancy
- •Known hypersensitivity to any ingredient of MyramistinTM
- •Previous participation in the trial
- •Parallel participation in any other trial during the previous 90 days before screening
- •History of alcohol or drug abuse
- •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)
- •Legal incapacity and / or other circumstances rendering the patients
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Myramistin (Drug)
Myramistin 0.02%
Experimental
干预措施: Myramistin (Drug)
Myramistin 0.005%
Experimental
干预措施: Myramistin (Drug)
Myramistin 0.01%
Experimental
干预措施: Myramistin (Drug)
结局指标
主要结局
Pain Intensity Differences
时间窗: 2 hours
The primary endpoint is the Summed Pain Intensity Differences (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 time-weighted differences from each measured time point to baseline after dosing using the 100mm Visual Analogue Scale (VAS) Sore Throat Pain Intensity Scale (STPIS).
次要结局
- Time to Pain Relief(72+/-2 hours)
- Tonsillo-Pharyngitis Assessment Scale(72+/-2 hours)
- Time to relief in Difficulty to Swallow(72+/-2 hours)
- Pain Intensity Differences(72+/-2 hours)
- Difficulty to Swallow Differences(72+/-2 hours)
- Percentage of symptom free patients(72+/-2 hours)
研究者
研究点 (5)
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