Overview

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

Status:
Active, not recruiting
Trial end date:
2021-02-28
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Daewon Pharmaceutical Co., Ltd.
Criteria
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