NCT07093697

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

Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW5121 Compared to DW51211 and DW51212

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Daewon Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Acute bronchitis is a common respiratory condition characterized by inflammation of the bronchial tubes, leading to symptoms such as coughing, sputum production, and discomfort. Effective treatment options with improved symptom control and safety profiles are needed. This Phase 3, randomized, double-blind, parallel-group, multi-center, active-controlled, superiority trial aims to evaluate the efficacy and safety of DW5121 compared to DW51211 and DW51212 in patients with acute bronchitis. Eligible participants were randomized in a 1:1:1 ratio to receive either DW5121, DW51211, or DW51212 for 7 days. The primary objective is to assess the change in total Bronchitis Severity Score (BSS) at Day 4 (±1 day) after drug administration, and to demonstrate the superiority of DW5121 compared to both comparators. The secondary objectives include: 1. Comparison of BSS score changes at Day 4 between DW5121 and each comparator, including statistical significance. 2. Evaluation of overall efficacy and safety of DW5121 relative to DW51211 and DW51212. Participants visited the study site at baseline, Day 4 (Visit 3), and Day 7 (Visit 4). A follow-up safety check (Visit 5) was conducted approximately 5 days after the last visit. Additional site visits or assessments were performed as necessary based on investigator's discretion to monitor adverse events. This study provides important data on the potential benefits of DW5121 in managing symptoms of acute bronchitis, with an emphasis on both clinical efficacy and patient safety.

Conditions

• Acute Bronchitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-28
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2025-07-30
• Last updated: 2025-07-30

Locations

8 sites across 1 country: South Korea