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Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis

NCT02151734•Korea United Pharm. Inc.

Summary

This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis. The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.

Eligibility

Age

12 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients aged 12-75 years old
•A total score of BSS ≥ 5
•The duration of symptoms had to be less than 14 days and no chronic pulmonary disease
•Patients who voluntarily sign a written informed consent to participate in the trial

Exclusion Criteria

•Indication for antibiotic treatment(e.g. severe respiratory infection)
•Allergic bronchial asthma
•Tendency to bleed
•Severe heart, renal, or liver diseases or decline of immune function
•Chronic obstructive pulmonary disease
•Known or supposed hypersensitivity to investigational medication
•Treatment with antibiotics during the past 4 weeks prior to inclusion in the trial
•Women during pregnancy or lactation period
•Clinically significant abnormal values in the screening test(more than twice the upper limit of normal range for ALT, AST, BUN, and Serum Creatinine)
•Participation in any other trial within 30 days prior to inclusion in the trial
+1 more criteria

Key Dates

Start Date

August 1, 2013

Primary Completion Date

December 1, 2013

Last Updated

May 30, 2014

Enrollment

242

ACTUAL participants

Conditions

Acute Bronchitis

Interventions

KALOMIN™ Tab.

DRUG

Umckamin syrup

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis

Inclusion Criteria

Exclusion Criteria

To Evaluate the Efficacy and Safety of ALC-2203 in Patients With Acute Bronchitis

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

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