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A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab in Acute Bronchitis Patients

NCT03654196 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2019-02-12

No results posted yet for this study

Summary

A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis patients

Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject

Conditions

  • Acute Bronchitis

Interventions

DRUG

HL301(Experimental)

Total 7 days of treatment and The daily dose is as follows \[Morning: HL301 1Tab + Placebo of Umkamin 1Tab\] \[Noon: Placebo of Umkamin 1Tab\] \[Evening: HL301 1Tab + Placebo of Umkamin 1Tab\]

DRUG

Umkamin(Active Comparator)

Total 7 days of treatment and The daily dose is as follows \[Morning: Placebo of HL301 1Tab + Umkamin 1Tab\] \[Noon: Umkamin 1Tab\] \[Evening: Placebo of HL301 1Tab + Umkamin 1Tab\]

Sponsors & Collaborators

  • Hanlim Pharm. Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2018-09-21
Completion
2018-09-21

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 NCT03654196 on ClinicalTrials.gov