A Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms
NCT ID: NCT03722914
Last Updated: 2018-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
220 participants
INTERVENTIONAL
2018-03-01
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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benzonatate soft capsules group
Benzonatate 200 mg
200 mg/pellet, 1pellet/time, 3times/day
control group
blank control 0mg
0 mg/pellet, 1pellet/time, 3times/day
Interventions
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Benzonatate 200 mg
200 mg/pellet, 1pellet/time, 3times/day
blank control 0mg
0 mg/pellet, 1pellet/time, 3times/day
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Cao Zhaolong, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Beijing hospital
Beijing, Beijing Municipality, China
Beijing luhe hospital affiliated to capital medical university
Beijing, Beijing Municipality, China
Beijing pinggu district hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Second affiliated hospital of Harbin medical university
Harbin, Heilongjiang, China
Zhengzhou first people's hospital
Zhengzhou, Henan, China
Second Hospital of Xiangya
Changsha, Hunan, China
Affiliated hospital of Inner Mongolia medical university
Hohhot, Inner Mongolia, China
Inner Mongolia autonomous region people's hospital
Hohhot, Inner Mongolia, China
First hospital of jilin university
Changchun, Jilin, China
Jilin Province People's Hospital
Changchun, Jilin, China
Affiliated Zhongshan Hospital Dalian University
Dalian, Liaoning, China
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Central hospital of yangpu district, Shanghai
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Guo Yanfei, Master
Role: primary
Xu Zhenyang, Master
Role: primary
Jin Xiuhong, Master
Role: primary
Cao Zhaolong, M.D.
Role: primary
Chen Hong, Master
Role: primary
Chang Shuangxi, Master
Role: primary
Chen Ping, M.D.
Role: primary
Wang Lihong, Master
Role: primary
Yun Chunmei, Master
Role: primary
Peng Liping, M.D.
Role: primary
Li Hui, M.D.
Role: primary
Pei Fuyang, Master
Role: primary
Kang Jian, M.D.
Role: primary
Xu Xiaowen, Master
Role: primary
Other Identifiers
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EY20170501
Identifier Type: -
Identifier Source: org_study_id
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