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A Study to Evaluate the Efficacy and Safety of DW5121 Compared to DW51211 and DW51212

NCT07093697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2025-07-30

No results posted yet for this study

Summary

This is a Phase 3, randomized, double-blind, active-controlled, parallel-group, multi-center clinical trial to evaluate the efficacy and safety of DW5121 compared to DW51211 and DW51212 in patients with acute bronchitis. The primary objective is to demonstrate the superiority of DW5121 over DW51211 and DW51212 by comparing the change in total Bronchitis Severity Score (BSS) at Day 4 after administration. Approximately equal numbers of patients were randomized in a 1:1:1 ratio to receive DW5121, DW51211, or DW51212 for 7 days. Efficacy and safety assessments were conducted at Day 4 and Day 7, with a follow-up contact approximately 5 days after the end of treatment to monitor adverse events.

Conditions

  • Acute Bronchitis

Interventions

DRUG

DW5121

Participants receive DW5121, 2 tablets orally, DW51211 Placebo, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days

DRUG

DW51211

Participants receive DW5121 placebo, 2 tablets orally, DW51211, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days

DRUG

DW51212

Participants receive DW5121 placebo, 2 tablets orally, DW51211 placebo, 2 tablets orally, DW51212 , 1 tablets orally, 3 times a day after meals for 7 days

Sponsors & Collaborators

  • Daewon Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jaejeong Shim, Principal Investigator · Korea University Guro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2025-05-27
Completion
2025-05-27

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093697 on ClinicalTrials.gov