NCT01658020

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P25-P50 for phase_3 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2012

Typical duration for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2 months until next milestone

Results Posted

Study results publicly available

September 17, 2014

Completed
Last Updated

October 13, 2014

Status Verified

October 1, 2014

Enrollment Period

1.4 years

First QC Date

July 25, 2012

Results QC Date

September 1, 2014

Last Update Submit

October 2, 2014

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Acute exacerbation of Chronic obstructive pulmonary diseaseAcute ExacerbationChronic obstructive pulmonary disease(COPD)ZabofloxacinMoxifloxacin

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Clinical Response in the Clinical Population

    36days

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

    10days

  • Microbiological Response Rate

    10days

  • Change in EXACT-PRO Score

    10 days

  • Change in CAT Scores

    10 days

Study Arms (2)

DW224

EXPERIMENTAL

Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days

Drug: Zabofloxacin

Avelox

ACTIVE COMPARATOR

Moxifloxacin 400mg tablet P.O. once daily for 7days

Drug: Moxifloxacin

Interventions

ZabofloxacinDRUG

Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days

Also known as: DW224
DW224
MoxifloxacinDRUG

Moxifloxacin 400mg tablet P.O. once daily for 7days

Also known as: Avelox
Avelox

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31920016DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

zabofloxacinMoxifloxacin

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Principal Investigator
Organization
Asan Midical Center
ymoh55@amc.seoul.kr
+82-2-3010-3136

Study Officials

  • Yeon-Mok Oh, M.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

  • Sang-Do Lee, M.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2012

First Posted

August 6, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2014

Study Completion

August 1, 2014

Last Updated

October 13, 2014

Results First Posted

September 17, 2014

Record last verified: 2014-10

Locations

KR(1)