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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03722914
Recruitment Status : Unknown
Verified March 2018 by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Cough Drug: Benzonatate 200 mg Drug: blank control 0mg Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentric Randomized Double-blind Placebo-controlled Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
Drug Information available for: Benzonatate

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: benzonatate soft capsules group Drug: Benzonatate 200 mg
200 mg/pellet, 1pellet/time, 3times/day
Placebo Comparator: control group Drug: blank control 0mg
0 mg/pellet, 1pellet/time, 3times/day


Outcome Measures
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Primary Outcome Measures :
  1. reducion of cough symptoms total scores [ Time Frame: 7days ]
    The reduction of cough symptoms will be evaluated by comparative score index basal and final score


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722914


Contacts
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Contact: Lou Kun, Master 0311-67808817 loukun@mail.ecspc.com

Locations
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China, Beijing
Beijing hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Guo Yanfei, Master         
Beijing luhe hospital affiliated to capital medical university Recruiting
Beijing, Beijing, China, 100000
Contact: Xu Zhenyang, Master         
Beijing pinggu district hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Jin Xiuhong, Master         
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Cao Zhaolong, M.D.         
China, Heilongjiang
Second affiliated hospital of Harbin medical university Recruiting
Harbin, Heilongjiang, China, 150000
Contact: Chen Hong, Master         
China, Henan
Zhengzhou first people's hospital Recruiting
Zhengzhou, Henan, China, 450000
Contact: Chang Shuangxi, Master         
China, Hunan
Second Hospital of Xiangya Recruiting
Changsha, Hunan, China, 410000
Contact: Chen Ping, M.D.         
China, Inner Mongolia
Affiliated hospital of Inner Mongolia medical university Recruiting
Hohhot, Inner Mongolia, China, 010000
Contact: Wang Lihong, Master         
Inner Mongolia autonomous region people's hospital Recruiting
Hohhot, Inner Mongolia, China, 010000
Contact: Yun Chunmei, Master         
China, Jilin
First hospital of jilin university Recruiting
Changchun, Jilin, China, 130000
Contact: Peng Liping, M.D.         
Jilin Province People's Hospital Recruiting
Changchun, Jilin, China, 130000
Contact: Li Hui, M.D.         
China, Liaoning
Affiliated Zhongshan Hospital Dalian University Recruiting
Dalian, Liaoning, China, 116000
Contact: Pei Fuyang, Master         
First Affiliated Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110000
Contact: Kang Jian, M.D.         
China, Shanghai
Central hospital of yangpu district, Shanghai Recruiting
Shanghai, Shanghai, China, 200000
Contact: Xu Xiaowen, Master         
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Principal Investigator: Cao Zhaolong, M.D. Peking University People's Hospital
More Information
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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03722914    
Other Study ID Numbers: EY20170501
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Benzonatate
Antitussive Agents
Respiratory System Agents