Clinical Trial to Evaluate the Efficacy and Safety of 'DW... | NCT04260555

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

NCT04260555

Sponsor

Daewon Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Feb 7, 2020Actual

Enrollment

204Estimated

Phase

Phase 3

Conditions

Acute Bronchitis

Interventions

DW1601
DW16011
DW16012

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2018Actual

Primary Completion Date

Dec 9, 2019Actual

Completion Date

Feb 28, 2021Estimated

First Submitted Date

Feb 5, 2020

First Submission Date that Met QC Criteria

Feb 5, 2020

First Posted Date

Feb 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2020

Last Update Posted Date

Feb 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

204Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TEST	Experimental	tid PO, DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml	Drug: DW1601
Reference 1	Active Comparator	tid PO, Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml	Drug: DW16011
Reference 2	Active Comparator	tid PO, Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml	Drug: DW16012

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DW1601	Drug	Total 7 days of treatment and The daily dose is tid. (DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml)	TEST

Measure	Description	Time Frame
Bronchitis Severity Score(BSS)		Day 4

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Guro Hospital		Seoul		08308	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001991	Bronchitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided