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

NCT ID: NCT02151734

Last Updated: 2014-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Bronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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KALOMIN™ Tab.

KALOMIN™ Tab./Placebo to Umckamin syrup

Group Type EXPERIMENTAL

KALOMIN™ Tab.

Intervention Type DRUG

Umckamin syrup

Umckamin syrup/Placebo to KALOMIN™ Tab.

Group Type ACTIVE_COMPARATOR

Umckamin syrup

Intervention Type DRUG

Interventions

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KALOMIN™ Tab.

Intervention Type DRUG

Umckamin syrup

Intervention Type DRUG

Eligibility Criteria

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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
* Unsuitable patients for enrollment in the opinion of the investigator
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea United Pharm. Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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KUP-KLM_301

Identifier Type: -

Identifier Source: org_study_id