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

Information source: Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Zabofloxacin (Drug); Moxifloxacin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Dong Wha Pharmaceutical Co. Ltd.

Official(s) and/or principal investigator(s):
Yeon-Mok Oh, M.D., Principal Investigator, Affiliation: Asan Medical Center
Sang-Do Lee, M.D., Principal Investigator, Affiliation: Asan Medical Center

Summary

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

Clinical Details

Official title: Clinical Trials to Evaluate Efficacy and Safety of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg After Multi-dose Oral Administration in Patients With Acute Bacterial Exacerbation of Chronic Obstructive Pulmonary Disease.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Clinical Response in the Clinical Populations

Secondary outcome:

Clinical Response in the Clinical Population

Clinical Cure Rate in the Microbiological Per Protocol(PP) Population

Microbiological Response Rate

Change in EXACT-PRO Score

Change in CAT Scores

Detailed description: 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.

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Asan Medical Center, Seoul, Korea, Republic of
Additional Information

Asan Medical Center

Dong Wha Pharm. Co. Ltd.

Starting date: August 2012
Last updated: October 2, 2014

Page last updated: August 23, 2015

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