A Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms
- Registration Number
- NCT03722914
- Lead Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Brief Summary
The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 220
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group blank control 0mg - benzonatate soft capsules group Benzonatate 200 mg -
- Primary Outcome Measures
Name Time Method reducion of cough symptoms total scores 7days The reduction of cough symptoms will be evaluated by comparative score index basal and final score
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Beijing luhe hospital affiliated to capital medical university
🇨🇳Beijing, Beijing, China
Beijing pinggu district hospital
🇨🇳Beijing, Beijing, China
Affiliated hospital of Inner Mongolia medical university
🇨🇳Hohhot, Inner Mongolia, China
Beijing hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Second affiliated hospital of Harbin medical university
🇨🇳Harbin, Heilongjiang, China
Zhengzhou first people's hospital
🇨🇳Zhengzhou, Henan, China
Second Hospital of Xiangya
🇨🇳Changsha, Hunan, China
Inner Mongolia autonomous region people's hospital
🇨🇳Hohhot, Inner Mongolia, China
First hospital of jilin university
🇨🇳Changchun, Jilin, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
Affiliated Zhongshan Hospital Dalian University
🇨🇳Dalian, Liaoning, China
First Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Central hospital of yangpu district, Shanghai
🇨🇳Shanghai, Shanghai, China