A Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms

Last updated: October 25, 2018
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Overall Status: Trial Status Unknown

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03722914
EY20170501
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age between 18 and 75 years of age;

  2. the onset time is more than 3 days and less than 8 weeks;

  3. dry cough, the total score of cough symptom in day and night is greater than 4;

  4. Willing to sign informed consent.

Exclusion

Exclusion Criteria:

  1. allergic person or known to the test drug containing ingredients (including benzo,soybean oil, glycerin, gelatin) allergy;

  2. the cough symptoms are caused by bronchial asthma, tuberculosis, pneumoconiosis,bronchiectasis, tumor and other diseases that have been clearly diagnosed.

  3. coughers caused by drugs;

  4. respiratory depression or airway obstruction;

  5. patients with uncontrolled diabetes or hypertension;

  6. having difficulty in swallowing or affecting drug absorption, such as active pepticulcer and acute gastritis;

  7. patients with severe hematopoietic system, nervous system, mental illness (includingalcohol and substance abuse) or immunodeficiency diseases;

  8. 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).

  9. women during pregnancy or lactation or women who are preparing for pregnancy orlactation during the trial;

  10. in the first 3 months of screening, any other experimental drug treatment wasaccepted;

  11. Failure to comply with test plans or other conditions that other researchers believeis not appropriate for the group.

Study Design

Total Participants: 220
Study Start date:
March 01, 2018
Estimated Completion Date:
July 31, 2019

Study 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.

Connect with a study center

  • Beijing hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Beijing luhe hospital affiliated to capital medical university

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Beijing pinggu district hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Second affiliated hospital of Harbin medical university

    Harbin, Heilongjiang 150000
    China

    Active - Recruiting

  • Zhengzhou first people's hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Second Hospital of Xiangya

    Changsha, Hunan 410000
    China

    Active - Recruiting

  • Affiliated hospital of Inner Mongolia medical university

    Hohhot, Inner Mongolia 010000
    China

    Active - Recruiting

  • Inner Mongolia autonomous region people's hospital

    Hohhot, Inner Mongolia 010000
    China

    Active - Recruiting

  • First hospital of jilin university

    Changchun, Jilin 130000
    China

    Active - Recruiting

  • Jilin Province People's Hospital

    Changchun, Jilin 130000
    China

    Active - Recruiting

  • Affiliated Zhongshan Hospital Dalian University

    Dalian, Liaoning 116000
    China

    Active - Recruiting

  • First Affiliated Hospital of China Medical University

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

  • Central hospital of yangpu district, Shanghai

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

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