A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple dose of Zabofloxacin Tablet 400 mg.

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Detailed Description

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A Phase 3, Multicenter, Double Blind, Active Controlled, Randomized Study to Evaluate the Efficacy and Safety of Zabofloxacin for Patients with acute bacterial exacerbation of Chronic obstructive pulmonary disease.

Conditions

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Chronic Obstructive Pulmonary Disease

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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DW224

Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days

Group Type EXPERIMENTAL

Zabofloxacin

Intervention Type DRUG

Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days

Avelox

Moxifloxacin 400mg tablet P.O. once daily for 7days

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Moxifloxacin 400mg tablet P.O. once daily for 7days

Interventions

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Zabofloxacin

Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days

Intervention Type DRUG

Moxifloxacin

Moxifloxacin 400mg tablet P.O. once daily for 7days

Intervention Type DRUG

Other Intervention Names

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DW224 Avelox

Eligibility Criteria

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Inclusion Criteria

* Adult male or female same or older than age of 40
* Severity of acute exacerbation of Chronic obstructive pulmonary disease(COPD) must suit oral administration treatment
* Diagnosed as COPD before receiving written informed consent and outcome measure of spirometry testing confirmed as \[Ratio of Forced Expiratory Volume in 1 second(FEV1) to Forced Vital Capacity(FVC)\](FEV1/FVC) \< 0.7
* Subject showing following signs and symptoms:

(i)Purulent Sputum or Sputum level is increased (ii)Difficulty in breathing is increased
* Female subjects who might be pregnant must do pregnancy test and results should be negative before randomization is done. She must receive written informed consent form (NOTE: Subject who has used single hormone contraception for pregnancy control or has not been more than 1 year after Tubule ligation and menopause are excluded from the study)
* Subject who can agree and sign written informed consent form approved by Institutional Review Board(IRB) before participating in study and follow study requirements

Exclusion Criteria

* Subject who administered excess daily dose of antimicrobial/antibiotics in past 72 hours before receiving written consent
* Diagnosed to have pneumonia by taking chest X-ray in past 48 hours before receiving written consent
* Diagnosed to have infectious diseases or such diseases results in complications before receiving written consent (NOTE: Septic shock, Bronchiectasis, Lung abscess, Pneumonia, Active tuberculosis, Pulmonary malignancy, Cystic fibrosis, Empyema, Asthma)
* Have kidney or liver diseases who correspond following criteria:

(i) Creatinine Clearance(CCr) \< 50 mL/min (ii) Blood Urea Nitrogen(BUN) ≥ 30 mg/dl (iii) Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) \> 3 x Upper Limit Normal(ULN) (iv) Total bilirubin \> 2 x ULN (v) Alkaline Phosphatase(ALP) \> 2 x ULN.
* Organic gastrointestinal disorder having abnormal absorption problem condition in past 6 months before receiving written consent (NOTE: Active Crohn's disease, active ulcerative colitis)
* Diagnosed to have neutropenia where absolute neutrophil count is \< 1,000cells/mm3 (NOTE: Even though subject neutrophil count is \< 1,000cells/mm3, if it is acute infection, subject maybe possible to participate)
* Chronic Hepatitis B carrier
* Have proof that subject is Hepatitis C carrier or have Hepatitis C antibody
* Immunodeficiency diseases such as HIV positive, AIDS, Bone marrow transplant or leukemia
* Have medical history of hypersensitive reaction to antibiotics of fluoroquinolones
* Have medical history of seizure or administration of anti-seizure drug in past 1 year before receiving written consent (NOTE: Epilepsy, Convulsions, Myasthenia gravis)
* Medical history of ventricular arrhythmia
* Medical history of QTc prolongation or currently administering drug that delays QTc interval (NOTE: QTc prolongation means QTc interval \> 450 msec)
* Complex infections or diseases that can effect study assessment or need long-term antibiotic treatment exceeding 7 days
* Subject who has participated in Clinical trials or Bioequivalence test in past 30 days before receiving written consent
* Clinically significant by observations considered as unsuitable based on medical judgement by investigators where current condition can effect quality of safety or data

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No