EUCTR2016-003962-24-DE进行中（未招募）1 期
A multi-centre, randomized, placebo-controlled, double-blind, parallel-group study investigating safety and efficacy of a sore throat lozenge in the symptomatic treatment of patients with acute pharyngitis. - DoriPha II
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
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
- •male and female outpatients aged =18 years
- •signed informed consent form
- •clinically diagnosed acute pharyngitis (Tonsillo-Pharyngitis Assessment (TPA) =5)
- •recent onset of symptoms (=24 hours)
- •pain intensity of =8 on a 11-point numeric rating scale
- •difficulty in swallowing (100-mm VAS =50 mm)
- •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 320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 320
排除标准
- •patients with strong suspicion of streptococcus A infection (McIsaac Score =3)
- •another acute episode of pharyngitis within the last 7 days prior to screening (the current acute pharyngitis which started within the last 24 hours is not meant)
- •positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat
- •purulent tonsillitis
- •severe inflammations of the throat or throat pain that are accompanied by high fever (= 38,5°C, oral (sublingual)), headache, nausea and/or vomiting
- •the use of systemic antibiotics / local antibiotics in the throat area during the study and within the previous 7 days prior to screening
- •the use of any systemic analgesics / local analgesics in the throat area (e.g. non-steroidal drugs, ASA (> 100 mg), paracetamol) during the study or within the previous 36 hours prior to screening
- •the use of any systemic anti-inflammatory drug / local anti-inflammatory drug in the throat area (e.g. glucocorticoids) during the study or within the previous 4 weeks prior to screening
- •the use of local anesthetics for treatment of sore throat during the study or within the previous 2 days prior to screening
- •the use of any other ‘sore throat medication’ (e.g. lozenges, drops, sprays) or other cold medication” that could interfere the study results during the study and within the previous 7 days prior to screening
- •the use of any systemic or local (i.e. in the throat area) antihistamines started within 2 weeks prior to screening
- •major wounds of the mouth and throat
- •immunodeficiency disorders (e.g. organ transplantation, HIV infection)
- •severe neurologic and/or psychiatric disorders (including acute depressive mood / acute episode of depression)
- •malignant ENT disorders within the previous 5 years
- •known hypersensitivity to any of the ingredients of the study medication
- •fructose intolerance
- •women of child-bearing potential who do not use a highly effective method of contraception, that is the case when the Pearl Index of the contraceptive measure is =1
- •pregnancy and lactation
- •participation in another clinical study during the study and within the previous 30 days prior to screening
- •presence of drug or alcohol abuse
- •persons who are institutionalized by court order or regulatory action
- •patients, who are members of the staff of the study center, staff of the sponsor or involved Clinical Research Organization (CRO), the investigator him- / herself or close relatives of the investigator
- •legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the study
研究者
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