NCT06244615已完成不适用
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of an Antiviral Mouth and Throat Rinse for the Treatment of Acute Sore Throat (Upper Respiratory Tract Infection e.g., Pharyngitis/Laryngitis)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo)
研究概览
简要总结
The aim of this study is to confirm the efficacy, safety and tolerability of the Mouth and Throat Rinse in adult participants with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects having clinical signs and symptoms of recent (less than 48 h) acute sore throat (upper respiratory tract infection) without signs of lower respiratory tract infection (total severity score for throat irritation baseline value ≥ 4).
- •Centor Score of 0 to 3 points at screening.
- •Female and male subjects with 18-75 years of age.
排除标准
- •Known allergy to any of the components in the investigational product (Placebo or Verum) (i.e. SLS).
- •Centor Score of 4 points at screening.
- •Presence of exanthema.
- •Presence of oral mucosal plaques e.g., soor.
- •Presence of bacterial infection of the upper respiratory tract (confirmed by rapid screening test).
结局指标
主要结局
Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo)
时间窗: Day 1 vs Day 4
A total severity score for throat irritation will be calculated at each visit as the sum of the subjective and objective symptoms. Each of the four criteria on a scale from 0 to 4: 1\. soreness, 2. difficulty swallowing (rated by the subject), 3. mucosal swelling of the throat and 4. oropharyngeal color (erythema) (assessed by the investigator)
次要结局
- Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo with respect to the subjective symtoms of throat soreness and difficulty swallowing(Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1)
- Global judgement of efficacy by the investigator(Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14)
- Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the recovery time(Day 1 vs. Day 7 and Day 1 vs. Day 14)
- Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the presence of Metapneumovirus and Bocavirus(Day 1 vs. Day 4)
- Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo by analysing the detection of viruses(Day 1 vs. Day 2,Day 1 vs. Day 4, Day 1 vs. Day 7 and Day 1 vs. Day 14)
- Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the proportion of rebound after treatment phase(Day 1 vs. Day 7 and Day 1 vs. Day 14)
- Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the need for further medical intervention or treatments such as rescue therapy or pain medication(Day 1 vs. Day 7 and Day 1 vs. Day 14)
- Global judgement of efficacy by the patient(Day 1 vs. Day 2, Day 1 vs. Day 7, Day 1 vs. Day 14)
- Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the objective symptoms of mucous swelling and oropharyngeal color (erythema)(Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1)
- Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the proportion of expansion of the symptoms (e.g., subsequent bronchitis)(Day 1 vs. Day 7 and Day 1 vs. Day 14)
- Evaluate the safety of the Verum Mouth and Throat Rinse in adult subjects with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis)(Day 1, Day 2, Day 3, Day 7±1, Day 14±1)
研究者
研究点 (2)
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