Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04260555
Recruitment Status : Active, not recruiting
First Posted : February 7, 2020
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Acute Bronchitis Drug: DW1601 Drug: DW16011 Drug: DW16012 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
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
Actual Study Start Date : December 20, 2018
Actual Primary Completion Date : December 9, 2019
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

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)




Primary Outcome Measures :
  1. Bronchitis Severity Score(BSS) [ Time Frame: Day 4 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260555


Locations
Layout table for location information
Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of, 08308
Sponsors and Collaborators
Daewon Pharmaceutical Co., Ltd.

Layout table for additonal information
Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04260555    
Other Study ID Numbers: DW1601-301
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes