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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong Wha Pharmaceutical Co. Ltd.
• Collaborators: Ajou University; Asan Medical Center; Bundang CHA Hospital; Catholic University of Korea Saint Paul's Hospital; Chonbuk National University Hospital; Chonnam National University Hospital; Chosun University Hospital; Chungbuk National University; Chungnam National University Hospital; DongGuk University; Ewha Womans University Mokdong Hospital; Gachon University Gil Medical Center; Gyeongsang National University Hospital; Hallym University Medical Center; Hanyang University; Incheon St.Mary's Hospital; Inje University; Kangdong Sacred Heart Hospital; KangWon National University Hospital; Keimyung University Dongsan Medical Center; Konkuk University Medical Center; Konyang University Hospital; Korea University Anam Hospital; Kyunghee University Medical Center; Masan Samsung Hospital, South Korea; Severance Hospital; The Catholic University of Korea; Ulsan University Hospital; Wonju Severance Christian Hospital; Yeungnam University; Yeungnam University Hospital
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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