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NCT04260555 Clinical Trial

Clinical Trial to Evaluate the Efficacy and Safety of 'DW1601' in Acute Bronchitis

Acute Bronchitis Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04260555
Other study ID # DW1601-301
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 20, 2018
Est. completion date February 28, 2021

Study information
Verified date February 2020
Source Daewon Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 204
Est. completion date February 28, 2021
Est. primary completion date December 9, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years to 79 Years
Eligibility Inclusion Criteria:

- Both gender, 19 years = age = 80 years

- Bronchitis Severity Score* = 5point at Visit 2 (Randomized Visit)

- Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)

- Those who can comply with the requirements of clinical trials

- Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

- Patients who investigators determines to severe respiratory disease that would interfere with study assessment

- Patients with systemic infections requiring systemic antibiotic therapy

- patient with hemostatic disorder

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DW1601
Total 7 days of treatment and The daily dose is tid. (DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml)
• DW16011
Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml)
• DW16012
Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml)

Locations
Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bronchitis Severity Score(BSS) Day 4
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