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Trial record 30 of 507 for:    MOXIFLOXACIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01658020
Recruitment Status : Completed
First Posted : August 6, 2012
Results First Posted : September 17, 2014
Last Update Posted : October 13, 2014
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 Hospital
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
Information provided by (Responsible Party):
Dong Wha Pharmaceutical Co. Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Zabofloxacin
Drug: Moxifloxacin
Enrollment 345
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DW224 Avelox
Hide Arm/Group Description Zabofloxacin 400mg tablet P.O. once daily for 5days and Placebo P.O. once daily Moxifloxacin 400mg tablet P.O. once daily for 7days
Period Title: Overall Study
Started 175 167
Completed 167 158
Not Completed 8 9
Reason Not Completed
Adverse Event             3             3
Lost to Follow-up             1             0
Withdrawal by Subject             4             5
Protocol Violation             0             1
Arm/Group Title DW224 Avelox Total
Hide Arm/Group Description Zabofloxacin 367mg tablet P.O. once daily for 3 days and then placebo P.O. once daily for 2 days Moxifloxacin 400mg tablet P.O. once daily for 7 days Total of all reporting groups
Overall Number of Baseline Participants 175 167 342
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 175 participants 167 participants 342 participants
67.76  (7.79) 68.40  (8.04) 68.07  (7.91)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 167 participants 342 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
97
  55.4%
93
  55.7%
190
  55.6%
>=65 years
78
  44.6%
74
  44.3%
152
  44.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 167 participants 342 participants
Female
22
  12.6%
8
   4.8%
30
   8.8%
Male
153
  87.4%
159
  95.2%
312
  91.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 175 participants 167 participants 342 participants
175 167 342
1.Primary Outcome
Title Clinical Response in the Clinical Populations
Hide Description 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.
Time Frame 10days
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title DW224 Avelox
Hide Arm/Group Description:
Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
Moxifloxacin 400mg tablet P.O. once daily for 7 days
Overall Number of Participants Analyzed 143 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.71
(81.15 to 92.28)
86.26
(80.36 to 92.16)
2.Secondary Outcome
Title Clinical Response in the Clinical Population
Hide Description 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.
Time Frame 36days
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title DW224 Avelox
Hide Arm/Group Description:
Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
Moxifloxacin 400mg tablet P.O. once daily 7 days
Overall Number of Participants Analyzed 143 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76.22
(69.25 to 83.20)
70.99
(63.22 to 78.76)
3.Secondary Outcome
Title Clinical Cure Rate in the Microbiological Per Protocol(PP) Population
Hide Description

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.

Time Frame 10days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DW224 Avelox
Hide Arm/Group Description:
Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
Moxifloxacin 400mg tablet P.O. once daily for 7 days
Overall Number of Participants Analyzed 43 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
88.37
(78.79 to 97.95)
94.87
(87.95 to 100.00)
4.Secondary Outcome
Title Microbiological Response Rate
Hide Description

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.

Time Frame 10days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DW224 Avelox
Hide Arm/Group Description:
Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
Moxifloxacin 400mg tablet P.O. once daily for 7 days
Overall Number of Participants Analyzed 43 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
67.44
(53.44 to 81.45)
79.49
(66.81 to 92.16)
5.Secondary Outcome
Title Change in EXACT-PRO Score
Hide Description

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.

Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title DW224 Avelox
Hide Arm/Group Description:
Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
Moxifloxacin 400mg tablet P.O. once daily for 7 days
Overall Number of Participants Analyzed 141 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-6.90  (9.59) -4.29  (9.72)
6.Secondary Outcome
Title Change in CAT Scores
Hide Description

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.

Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title DW224 Avelox
Hide Arm/Group Description:
Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
Moxifloxacin 400mg tablet P.O. once daily for 7 days
Overall Number of Participants Analyzed 139 130
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-4.46  (5.88) -2.48  (5.96)
Time Frame About 1.5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DW224 Avelox
Hide Arm/Group Description

Zabofloxacin Tablet 400mg given by oral administration

Moxifloxacin Tablet 400mg: multiple-dose

Moxifloxacin Tablet 400mg given by oral administration

Zabofloxacin Tablet 400mg: multiple-dose

All-Cause Mortality
DW224 Avelox
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DW224 Avelox
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/175 (0.00%)      0/167 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DW224 Avelox
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/175 (9.71%)      16/167 (9.58%)    
Cardiac disorders     
Palpitations  1  1/175 (0.57%)  1 0/167 (0.00%)  0
Eye disorders     
Vision blurred  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Gastrointestinal disorders     
Nausea  1  3/175 (1.71%)  3 4/167 (2.40%)  4
Dry mouth  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Diarrhoea  1  4/175 (2.29%)  4 1/167 (0.60%)  1
Dyspepsia  1  1/175 (0.57%)  1 0/167 (0.00%)  0
Vimiting  1  1/175 (0.57%)  1 0/167 (0.00%)  0
Abdominal discomfort  1  1/175 (0.57%)  1 0/167 (0.00%)  0
Abdominal pain  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Epigastric discomfort  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Stomatitis  1  0/175 (0.00%)  0 1/167 (0.60%)  1
General disorders     
Chest discomfort  1  2/175 (1.14%)  2 0/167 (0.00%)  0
Face oedema  1  1/175 (0.57%)  1 0/167 (0.00%)  0
Fatigue  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Oedema peripheral  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Infections and infestations     
Nasopharyngitis  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Investigations     
Glucose urine present  1  1/175 (0.57%)  1 0/167 (0.00%)  0
Red blood cell microcytes present  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Musculoskeletal and connective tissue disorders     
Flank pain  1  1/175 (0.57%)  1 0/167 (0.00%)  0
Nervous system disorders     
Dizziness  1  3/175 (1.71%)  3 1/167 (0.60%)  1
Headache  1  1/175 (0.57%)  1 1/167 (0.60%)  1
Tremor  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Paraesthesia  1  1/175 (0.57%)  1 0/167 (0.00%)  0
Somnolence  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Renal and urinary disorders     
Haematuria  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Respiratory, thoracic and mediastinal disorders     
COPD  1  1/175 (0.57%)  1 0/167 (0.00%)  0
Sputum retention  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Skin and subcutaneous tissue disorders     
Pruritus  1  1/175 (0.57%)  1 1/167 (0.60%)  1
Rash  1  1/175 (0.57%)  1 0/167 (0.00%)  0
Drug eruption  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Erythema  1  1/175 (0.57%)  1 0/167 (0.00%)  0
Vascular disorders     
Flushing  1  0/175 (0.00%)  0 1/167 (0.60%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principal Investigator
Organization: Asan Midical Center
Phone: +82-2-3010-3136
EMail: ymoh55@amc.seoul.kr
Layout table for additonal information
Responsible Party: Dong Wha Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT01658020     History of Changes
Other Study ID Numbers: DW224-III-3
First Submitted: July 25, 2012
First Posted: August 6, 2012
Results First Submitted: September 1, 2014
Results First Posted: September 17, 2014
Last Update Posted: October 13, 2014