A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg (DW224-III-3)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Chonbuk National University Hospital
Chosun University Hospital
Bundang CHA Hospital
Chungbuk National University
Kangdong Sacred Heart Hospital
Hanyang University
Asan Medical Center
Gachon University Gil Medical Center
The Catholic University of Korea
Konyang University Hospital
KangWon National University Hospital
Gyeongsang National University Hospital
Kyunghee University Medical Center
Korea University Anam Hospital
DongGuk University
Severance Hospital
Yeungnam University
Ulsan University Hospital
Ewha Womans University Mokdong Hospital
Inje University
Chonnam National University Hospital
Catholic University of Korea Saint Paul's Hospital
Incheon St.Mary's Hospital
Masan Samsung Hospital, South Korea
Konkuk University Medical Center
Keimyung University Dongsan Medical Center
Wonju Severance Christian Hospital
Hallym University Medical Center
Ajou University
Chungnam National University Hospital
Gangneung Asan Hospital
Information provided by (Responsible Party):
Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01658020
First received: July 25, 2012
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Zabofloxacin Tablet 400mg
Drug: Moxifloxacin Tablet 400mg
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Dong Wha Pharmaceutical Co. Ltd.:

Primary Outcome Measures:
  • Clinical Cure Rate in the clinical populations [ Time Frame: 10days ] [ Designated as safety issue: Yes ]
    Primary Efficacy


Secondary Outcome Measures:
  • Clinical cure Rate in the clinical population [ Time Frame: 36days ] [ Designated as safety issue: Yes ]
    Secondary Efficacy

  • Clinical cure Rate in the microbiological PP population [ Time Frame: 10days ] [ Designated as safety issue: Yes ]
    Secondary Efficacy

  • Microbiological response rate in the microbiological PP population [ Time Frame: 10,36days ] [ Designated as safety issue: Yes ]
    Secondary Efficacy

  • Change in EXACT-PRO score for clinical populations [ Time Frame: 10,36days ] [ Designated as safety issue: Yes ]
    Secondary Efficacy

  • Change in CAT scores for clinical populations [ Time Frame: 10,36days ] [ Designated as safety issue: Yes ]
    Secondary Efficacy


Other Outcome Measures:
  • Safety Assessment [ Time Frame: 36days ] [ Designated as safety issue: Yes ]
    Safety analysis is done to clinical ITT population and assessed by changes in numbers of results in Adverse Events monitoring, vital signs of populations laboratory examination.


Enrollment: 344
Study Start Date: August 2012
Estimated Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DW224
Zabofloxacin Tablet 400mg given by oral administration
Drug: Moxifloxacin Tablet 400mg
multiple-dose
Other Name: Avelox
Active Comparator: Avelox
Moxifloxacin Tablet 400mg given by oral administration
Drug: Zabofloxacin Tablet 400mg
multiple-dose
Other Name: DW224

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or female same or older than age of 40
  • Severity of acute exacerbation of COPD must suit oral administration treatment
  • Diagnosed as COPD before receiving written informed consent and outcome measure of spirometry testing confirmed as 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 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) CCr < 50 mL/min; (ii) BUN ≥ 30 mg/dl; (iii) ALT 또는 AST > 3 x ULN; (iv) Total bilirubin > 2 x ULN; (v) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658020

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong Wha Pharmaceutical Co. Ltd.
Chonbuk National University Hospital
Chosun University Hospital
Bundang CHA Hospital
Chungbuk National University
Kangdong Sacred Heart Hospital
Hanyang University
Asan Medical Center
Gachon University Gil Medical Center
The Catholic University of Korea
Konyang University Hospital
KangWon National University Hospital
Gyeongsang National University Hospital
Kyunghee University Medical Center
Korea University Anam Hospital
DongGuk University
Severance Hospital
Yeungnam University
Ulsan University Hospital
Ewha Womans University Mokdong Hospital
Inje University
Chonnam National University Hospital
Catholic University of Korea Saint Paul's Hospital
Incheon St.Mary's Hospital
Masan Samsung Hospital, South Korea
Konkuk University Medical Center
Keimyung University Dongsan Medical Center
Wonju Severance Christian Hospital
Hallym University Medical Center
Ajou University
Chungnam National University Hospital
Gangneung Asan Hospital
Investigators
Principal Investigator: Yeon-Mok Oh, M.D. Asan Medical Center
Principal Investigator: Sang-Do Lee, M.D. Asan Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT01658020     History of Changes
Other Study ID Numbers: DW224-III-3
Study First Received: July 25, 2012
Last Updated: January 17, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Dong Wha Pharmaceutical Co. Ltd.:
Acute exacerbation of Chronic obstructive pulmonary disease
Acute Exacerbation
COPD
Zabofloxacin
Moxifloxacin
Avelox
DW224-III-3
DW224
DW224a
DW224aa

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014