NCT04260555
Unknown
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- DW1601
- Conditions
- Acute Bronchitis
- Sponsor
- Daewon Pharmaceutical Co., Ltd.
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- Bronchitis Severity Score(BSS)
- Last Updated
- 6 years ago
Overview
Brief 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
Investigators
Eligibility 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
Arms & Interventions
TEST
tid PO, DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml
Intervention: DW1601
Reference 1
tid PO, Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml
Intervention: DW16011
Reference 2
tid PO, Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml
Intervention: DW16012
Outcomes
Primary Outcomes
Bronchitis Severity Score(BSS)
Time Frame: Day 4
Study Sites (1)
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