Clinical Trial to Evaluate the Efficacy and Safety of 'DW1601' in Acute Bronchitis
- Registration Number
- NCT04260555
- Lead Sponsor
- Daewon Pharmaceutical Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 204
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reference 2 DW16012 tid PO, Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml Reference 1 DW16011 tid PO, Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml TEST DW1601 tid PO, DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml
- Primary Outcome Measures
Name Time Method Bronchitis Severity Score(BSS) Day 4
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of