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

February 5, 2020 updated by: Daewon Pharmaceutical Co., Ltd.

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

204

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TEST
tid PO, DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml
Drug: DW1601
Total 7 days of treatment and The daily dose is tid. (DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml)
ACTIVE_COMPARATOR: Reference 1
tid PO, Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml
Drug: DW16011
Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml)
ACTIVE_COMPARATOR: Reference 2
tid PO, Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml
Drug: DW16012
Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bronchitis Severity Score(BSS)
Time Frame: Day 4
Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 20, 2018

Primary Completion (ACTUAL)

December 9, 2019

Study Completion (ANTICIPATED)

February 28, 2021

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (ACTUAL)

February 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW1601-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Bronchitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe