A Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms
A Multicentric Randomized Double-blind Placebo-controlled Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms
1 other identifier
interventional
220
1 country
14
Brief Summary
The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2018
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 25, 2018
CompletedFirst Posted
Study publicly available on registry
October 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedOctober 29, 2018
March 1, 2018
10 months
October 25, 2018
October 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
reducion of cough symptoms total scores
The reduction of cough symptoms will be evaluated by comparative score index basal and final score
7days
Study Arms (2)
benzonatate soft capsules group
ACTIVE COMPARATORcontrol group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Beijing hospital
Beijing, Beijing Municipality, 100000, China
Beijing luhe hospital affiliated to capital medical university
Beijing, Beijing Municipality, 100000, China
Beijing pinggu district hospital
Beijing, Beijing Municipality, 100000, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100000, China
Second affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150000, China
Zhengzhou first people's hospital
Zhengzhou, Henan, 450000, China
Second Hospital of Xiangya
Changsha, Hunan, 410000, China
Affiliated hospital of Inner Mongolia medical university
Hohhot, Inner Mongolia, 010000, China
Inner Mongolia autonomous region people's hospital
Hohhot, Inner Mongolia, 010000, China
First hospital of jilin university
Changchun, Jilin, 130000, China
Jilin Province People's Hospital
Changchun, Jilin, 130000, China
Affiliated Zhongshan Hospital Dalian University
Dalian, Liaoning, 116000, China
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000, China
Central hospital of yangpu district, Shanghai
Shanghai, Shanghai Municipality, 200000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cao Zhaolong, M.D.
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2018
First Posted
October 29, 2018
Study Start
March 1, 2018
Primary Completion
December 31, 2018
Study Completion
July 31, 2019
Last Updated
October 29, 2018
Record last verified: 2018-03