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

Primary Purpose

Acute Bronchitis

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DW1601
DW16011
DW16012
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bronchitis

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

TEST

Reference 1

Reference 2

Arm Description

tid PO, DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml

tid PO, Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml

tid PO, Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml

Outcomes

Primary Outcome Measures

Bronchitis Severity Score(BSS)

Secondary Outcome Measures

Full Information

First Posted
February 5, 2020
Last Updated
February 5, 2020
Sponsor
Daewon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04260555
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of 'DW1601' in Acute Bronchitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
February 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEST
Arm Type
Experimental
Arm Description
tid PO, DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml
Arm Title
Reference 1
Arm Type
Active Comparator
Arm Description
tid PO, Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml
Arm Title
Reference 2
Arm Type
Active Comparator
Arm Description
tid PO, Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml
Intervention Type
Drug
Intervention Name(s)
DW1601
Intervention Description
Total 7 days of treatment and The daily dose is tid. (DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml)
Intervention Type
Drug
Intervention Name(s)
DW16011
Intervention Description
Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml)
Intervention Type
Drug
Intervention Name(s)
DW16012
Intervention Description
Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml)
Primary Outcome Measure Information:
Title
Bronchitis Severity Score(BSS)
Time Frame
Day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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