A Multicentric Randomized Double-blind Placebo-controlled Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 220
- 试验地点
- 14
- 主要终点
- reducion of cough symptoms total scores
研究概览
简要总结
The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms.
详细描述
The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms. The study was designed to be randomized, double-blind, placebo-controlled.Subjects were randomly assigned to the benzonatate soft capsule group and the placebo group on a 1:1 basis。According to the regulatory requirements, 200 cases were planned to be included. Considering that poor efficacy of the placebo control group might lead to shedding, a 10% increase in shedding was achieved, and 220 cases were finally determined, with 110 cases in each group.
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
- •age between 18 and 75 years of age;
- •the onset time is more than 3 days and less than 8 weeks;
- •dry cough, the total score of cough symptom in day and night is greater than 4;
- •Willing to sign informed consent.
排除标准
- •allergic person or known to the test drug containing ingredients (including benzo, soybean oil, glycerin, gelatin) allergy;
- •the cough symptoms are caused by bronchial asthma, tuberculosis, pneumoconiosis, bronchiectasis, tumor and other diseases that have been clearly diagnosed.
- •coughers caused by drugs;
- •respiratory depression or airway obstruction;
- •patients with uncontrolled diabetes or hypertension;
- •having difficulty in swallowing or affecting drug absorption, such as active peptic ulcer and acute gastritis;
- •patients with severe hematopoietic system, nervous system, mental illness (including alcohol and substance abuse) or immunodeficiency diseases;
- •laboratory examination results are abnormal with clinical significance, among which: A.C r is higher than normal value; B.A LT and/or AST>2 times normal value upper limit (ULN).
- •women during pregnancy or lactation or women who are preparing for pregnancy or lactation during the trial;
- •in the first 3 months of screening, any other experimental drug treatment was accepted;
- •Failure to comply with test plans or other conditions that other researchers believe is not appropriate for the group.
研究组 & 干预措施
benzonatate soft capsules group
干预措施: Benzonatate 200 mg (Drug)
control group
干预措施: blank control 0mg (Drug)
结局指标
主要结局
reducion of cough symptoms total scores
时间窗: 7days
The reduction of cough symptoms will be evaluated by comparative score index basal and final score
次要结局
未报告次要终点