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

Cough Clinical Trial

Official title:

A Multicentric Randomized Double-blind Placebo-controlled Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03722914
• Other study ID #: EY20170501
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2018
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: Lou Kun, Master
• Phone: 0311-67808817
• Email: loukun[@]mail.ecspc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• Benzonatate 200 mg
200 mg/pellet, 1pellet/time, 3times/day
• blank control 0mg
0 mg/pellet, 1pellet/time, 3times/day

Locations

Country	Name	City	State
China	Beijing hospital	Beijing	Beijing
China	Beijing luhe hospital affiliated to capital medical university	Beijing	Beijing
China	Beijing pinggu district hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	First hospital of jilin university	Changchun	Jilin
China	Jilin Province People's Hospital	Changchun	Jilin
China	Second Hospital of Xiangya	Changsha	Hunan
China	Affiliated Zhongshan Hospital Dalian University	Dalian	Liaoning
China	Second affiliated hospital of Harbin medical university	Harbin	Heilongjiang
China	Affiliated hospital of Inner Mongolia medical university	Hohhot	Inner Mongolia
China	Inner Mongolia autonomous region people's hospital	Hohhot	Inner Mongolia
China	Central hospital of yangpu district, Shanghai	Shanghai	Shanghai
China	First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	Zhengzhou first people's hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reducion of cough symptoms total scores	The reduction of cough symptoms will be evaluated by comparative score index basal and final score	7days