NCT01658020已完成3 期
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.
Dong Wha Pharmaceutical Co. Ltd.1 个研究点 分布在 1 个国家目标入组 345 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- Clinical Response in the Clinical Populations
研究概览
简要总结
The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple dose of Zabofloxacin Tablet 400 mg.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
DW224
Experimental
Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days
干预措施: Zabofloxacin (Drug)
Avelox
Active Comparator
Moxifloxacin 400mg tablet P.O. once daily for 7days
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Clinical Response in the Clinical Populations
时间窗: 10days
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.
次要结局
- Microbiological Response Rate(10days)
- Change in EXACT-PRO Score(10 days)
- Clinical Response in the Clinical Population(36days)
- Clinical Cure Rate in the Microbiological Per Protocol(PP) Population(10days)
- Change in CAT Scores(10 days)
研究者
研究点 (1)
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