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

• Sponsor: Daewon Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04260555
• Collaborator: (none)
• Enrollment: 204
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 26.3
• Patients Per Site Per Month: 7.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Acute Bronchitis	Drug: DW1601; Drug: DW16011; Drug: DW16012	Phase 3

Study Design

• Study Type: Interventional
• Anticipated 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: Dec 20, 2018
• Actual Primary Completion Date: Dec 9, 2019
• Anticipated Study Completion Date: Feb 28, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Bronchitis Severity Score(BSS) [Day 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Guro Hospital	Seoul		Korea, Republic of	08308

Sponsors and Collaborators

• Daewon Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewon Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04260555
• Other Study ID Numbers: DW1601-301
• First Posted: Feb 7, 2020
• Last Update Posted: Feb 7, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bronchitis; Acute Disease

Study Results

No Results Posted as of Feb 7, 2020