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| Name | Class |
|---|---|
| Chonbuk National University Hospital | OTHER |
| Chosun University Hospital | OTHER |
| Bundang CHA Hospital | OTHER |
| Chungbuk National University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DW224 | Experimental | Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days |
|
| Avelox | Active Comparator | Moxifloxacin 400mg tablet P.O. once daily for 7days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zabofloxacin | Drug | Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response in the Clinical Populations | Clinical response corresponding clinical cure at Test of Cure visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate. | 10days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response in the Clinical Population | Clinical response corresponding clinical cure at End of Study visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate. | 36days |
| Clinical Cure Rate in the Microbiological Per Protocol(PP) Population |
Not provided
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
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| Name | Affiliation | Role |
|---|---|---|
| Yeon-Mok Oh, M.D. | Asan Medical Center | Principal Investigator |
| Sang-Do Lee, M.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31920016 | Derived | Yoon S, Kim TE, Kim TH, Na JO, Shin KC, Rhee CK, Jung SS, Choe KH, Yoo KH. Clinical Role of the Chronic Obstructive Pulmonary Disease Assessment Test in Prediction of the Response to Treatment for Exacerbations. J Korean Med Sci. 2020 Jan 13;35(2):e10. doi: 10.3346/jkms.2020.35.e10. |
| Label | URL |
|---|---|
| Asan Medical Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | DW224 | Zabofloxacin 400mg tablet P.O. once daily for 5days and Placebo P.O. once daily |
| FG001 | Avelox | Moxifloxacin 400mg tablet P.O. once daily for 7days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DW224 | Zabofloxacin 367mg tablet P.O. once daily for 3 days and then placebo P.O. once daily for 2 days |
| BG001 | Avelox | Moxifloxacin 400mg tablet P.O. once daily for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Response in the Clinical Populations | Clinical response corresponding clinical cure at Test of Cure visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate. | Per protocol population | Number | 95% Confidence Interval | percentage of participants | 10days |
|
About 1.5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DW224 | Zabofloxacin Tablet 400mg given by oral administration Moxifloxacin Tablet 400mg: multiple-dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Asan Midical Center | +82-2-3010-3136 | ymoh55@amc.seoul.kr |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C480202 | zabofloxacin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| OTHER |
| Kangdong Sacred Heart Hospital | OTHER |
| Hanyang University | OTHER |
| Asan Medical Center | OTHER |
| Gachon University Gil Medical Center | OTHER |
| The Catholic University of Korea | OTHER |
| Konyang University Hospital | OTHER |
| KangWon National University Hospital | OTHER |
| Gyeongsang National University Hospital | OTHER |
| Kyunghee University Medical Center | OTHER |
| Korea University Anam Hospital | OTHER |
| DongGuk University | OTHER |
| Severance Hospital | OTHER |
| Yeungnam University Hospital | OTHER |
| Ulsan University Hospital | OTHER |
| Ewha Womans University Mokdong Hospital | OTHER |
| Inje University | OTHER |
| Chonnam National University Hospital | OTHER |
| Catholic University of Korea Saint Paul's Hospital | OTHER |
| Incheon St.Mary's Hospital | OTHER |
| Masan Samsung Hospital, South Korea | OTHER |
| Konkuk University Medical Center | OTHER |
| Keimyung University Dongsan Medical Center | OTHER |
| Wonju Severance Christian Hospital | OTHER |
| Hallym University Medical Center | OTHER |
| Ajou University | OTHER |
| Chungnam National University Hospital | OTHER |
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| Moxifloxacin | Drug | Moxifloxacin 400mg tablet P.O. once daily for 7days |
|
|
Clinical response corresponding clinical cure in the microbiological per-protocol population. Microbiological responses were discriminated for the pathogens isolated from the respiratory secretion samples of subjects. |
| 10days |
| Microbiological Response Rate | Microbiological response rate in the microbiological per protocol(PP) population. Microbiological rate were discriminated for the pathogens isolated from the respiratory secretion samples of subjects. | 10days |
| Change in EXACT-PRO Score | The outcome measurement is Change in EXACT-PRO score for clinical populations at Test of cure visit. EXACT-PRO means that the questionnaires for Exacerbation of Chronic Pulmonary Disease Tool-Patient Reported Outcome of United BioSource Corporation(UBC) of USA that had been standardized, equipped with reliability and feasibility applicable to various COPD patients groups were used in order to quantitate frequency, severity and duration of acute exacerbation as a tool to measure acute exacerbation of COPD. EXACT-PRO is consisted of 14 questionnaire items were classified into 3 domains, Respiratory Distress Domain, Cough/Sputum Domain, and Chest Symptoms Domain. The Scores of each domain were to be summed into the domain raw summed score or converted into EXACT domain score according to the conversion table. The total score had value in the range from 0 to 100 and higher the value was, severer the respiratory symptoms were in evaluation. | 10 days |
| Change in CAT Scores | The outcome measurement is Change in CAT scores for clinical populations at Test of cure visit. CAT score means that COPD Assessment Test was used as a tool to assess the effects of COPD on physical, mental status and daily life. CAT is consisted of 8 items in total and each question item was scored from 0 point to 5 point. The scores of each question item were summed into the total score, which had values between 0 and 40. | 10 days |
| Dong Wha Pharm. Co. Ltd. | View source |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Clinical Response in the Clinical Population | Clinical response corresponding clinical cure at End of Study visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate. | Per protocol population | Number | 95% Confidence Interval | percentage of participants | 36days |
|
|
|
| Secondary | Clinical Cure Rate in the Microbiological Per Protocol(PP) Population | Clinical response corresponding clinical cure in the microbiological per-protocol population. Microbiological responses were discriminated for the pathogens isolated from the respiratory secretion samples of subjects. | Number | 95% Confidence Interval | Percentage of participants | 10days |
|
|
|
| Secondary | Microbiological Response Rate | Microbiological response rate in the microbiological per protocol(PP) population. Microbiological rate were discriminated for the pathogens isolated from the respiratory secretion samples of subjects. | Number | 95% Confidence Interval | Percentage of participants | 10days |
|
|
|
| Secondary | Change in EXACT-PRO Score | The outcome measurement is Change in EXACT-PRO score for clinical populations at Test of cure visit. EXACT-PRO means that the questionnaires for Exacerbation of Chronic Pulmonary Disease Tool-Patient Reported Outcome of United BioSource Corporation(UBC) of USA that had been standardized, equipped with reliability and feasibility applicable to various COPD patients groups were used in order to quantitate frequency, severity and duration of acute exacerbation as a tool to measure acute exacerbation of COPD. EXACT-PRO is consisted of 14 questionnaire items were classified into 3 domains, Respiratory Distress Domain, Cough/Sputum Domain, and Chest Symptoms Domain. The Scores of each domain were to be summed into the domain raw summed score or converted into EXACT domain score according to the conversion table. The total score had value in the range from 0 to 100 and higher the value was, severer the respiratory symptoms were in evaluation. | Per protocol population | Mean | Standard Deviation | scores on a scale | 10 days |
|
|
|
| Secondary | Change in CAT Scores | The outcome measurement is Change in CAT scores for clinical populations at Test of cure visit. CAT score means that COPD Assessment Test was used as a tool to assess the effects of COPD on physical, mental status and daily life. CAT is consisted of 8 items in total and each question item was scored from 0 point to 5 point. The scores of each question item were summed into the total score, which had values between 0 and 40. | Per protocol population | Mean | Standard Deviation | scores on a scale | 10 days |
|
|
|
| 0 |
| 175 |
| 17 |
| 175 |
| EG001 | Avelox | Moxifloxacin Tablet 400mg given by oral administration Zabofloxacin Tablet 400mg: multiple-dose | 0 | 167 | 16 | 167 |
| Dry mouth | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vimiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| COPD | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Red blood cell microcytes present | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |