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

• Status: Unknown status
• Trial end date: 2019-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Benzonatate

Criteria

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 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 peptic ulcer and acute gastritis;

7. patients with severe hematopoietic system, nervous system, mental illness (including alcohol 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 or lactation during the trial;

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

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