NCT04260555

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

February 5, 2020

Last Update Submit

February 5, 2020

Conditions

Acute Bronchitis

Outcome Measures

Primary Outcomes (1)

  • Bronchitis Severity Score(BSS)

    Day 4

Study Arms (3)

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

DW1601DRUG

Total 7 days of treatment and The daily dose is tid. (DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml)

TEST
DW16011DRUG

Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml)

Reference 1
DW16012DRUG

Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml)

Reference 2

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 7, 2020

Study Start

December 20, 2018

Primary Completion

December 9, 2019

Study Completion

February 28, 2021

Last Updated

February 7, 2020

Record last verified: 2020-02

Locations

KR(1)