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

Primary Purpose

Cough

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Benzonatate 200 mg
blank control 0mg
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing hospitalRecruiting
  • Beijing luhe hospital affiliated to capital medical universityRecruiting
  • Beijing pinggu district hospitalRecruiting
  • Peking University People's HospitalRecruiting
  • Second affiliated hospital of Harbin medical universityRecruiting
  • Zhengzhou first people's hospitalRecruiting
  • Second Hospital of XiangyaRecruiting
  • Affiliated hospital of Inner Mongolia medical universityRecruiting
  • Inner Mongolia autonomous region people's hospitalRecruiting
  • First hospital of jilin universityRecruiting
  • Jilin Province People's HospitalRecruiting
  • Affiliated Zhongshan Hospital Dalian UniversityRecruiting
  • First Affiliated Hospital of China Medical UniversityRecruiting
  • Central hospital of yangpu district, ShanghaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

benzonatate soft capsules group

control group

Arm Description

Outcomes

Primary Outcome Measures

reducion of cough symptoms total scores
The reduction of cough symptoms will be evaluated by comparative score index basal and final score

Secondary Outcome Measures

Full Information

First Posted
October 25, 2018
Last Updated
October 25, 2018
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03722914
Brief Title
A Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms
Official Title
A Multicentric Randomized Double-blind Placebo-controlled Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
July 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
benzonatate soft capsules group
Arm Type
Active Comparator
Arm Title
control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Benzonatate 200 mg
Intervention Description
200 mg/pellet, 1pellet/time, 3times/day
Intervention Type
Drug
Intervention Name(s)
blank control 0mg
Intervention Description
0 mg/pellet, 1pellet/time, 3times/day
Primary Outcome Measure Information:
Title
reducion of cough symptoms total scores
Description
The reduction of cough symptoms will be evaluated by comparative score index basal and final score
Time Frame
7days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lou Kun, Master
Phone
0311-67808817
Email
loukun@mail.ecspc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cao Zhaolong, M.D.
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo Yanfei, Master
Facility Name
Beijing luhe hospital affiliated to capital medical university
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Zhenyang, Master
Facility Name
Beijing pinggu district hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Xiuhong, Master
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cao Zhaolong, M.D.
Facility Name
Second affiliated hospital of Harbin medical university
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Hong, Master
Facility Name
Zhengzhou first people's hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Shuangxi, Master
Facility Name
Second Hospital of Xiangya
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Ping, M.D.
Facility Name
Affiliated hospital of Inner Mongolia medical university
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Lihong, Master
Facility Name
Inner Mongolia autonomous region people's hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Chunmei, Master
Facility Name
First hospital of jilin university
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Liping, M.D.
Facility Name
Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Hui, M.D.
Facility Name
Affiliated Zhongshan Hospital Dalian University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei Fuyang, Master
Facility Name
First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kang Jian, M.D.
Facility Name
Central hospital of yangpu district, Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Xiaowen, Master

12. IPD Sharing Statement

Learn more about this trial

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

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