EUCTR2015-003111-38-DE进行中（未招募）1 期
A double-blind, randomized, placebo-controlled, parallel-group study comparing safety and efficacy of Dorithricin® lozenges with placebo in the symptomatic treatment of patients with acute pharyngitis - DoriPha
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
- 300
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)
- •Moderate or severe pain intensity (11-point numerical scale =6)
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
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
- •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 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
- •Major wounds of the mouth and throat
- •Immunodeficiency disorders (e.g. organ transplantation, HIV infection)
- •Severe neurologic and/or psychiatric disorders
- •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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