Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg (NCT NCT01658020)

Last Updated: 2014-10-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

345 participants

Primary outcome timeframe

10days

Results posted on

2014-10-13

Participant Flow

Participant milestones

Participant milestones
Measure	DW224 Zabofloxacin 400mg tablet P.O. once daily for 5days and Placebo P.O. once daily	Avelox Moxifloxacin 400mg tablet P.O. once daily for 7days
Overall Study STARTED	175	167
Overall Study COMPLETED	167	158
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Reasons for withdrawal
Measure	DW224 Zabofloxacin 400mg tablet P.O. once daily for 5days and Placebo P.O. once daily	Avelox Moxifloxacin 400mg tablet P.O. once daily for 7days
Overall Study Adverse Event	3	3
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	4	5
Overall Study Protocol Violation	0	1

Baseline Characteristics

A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DW224 n=175 Participants Zabofloxacin 367mg tablet P.O. once daily for 3 days and then placebo P.O. once daily for 2 days	Avelox n=167 Participants Moxifloxacin 400mg tablet P.O. once daily for 7 days	Total n=342 Participants Total of all reporting groups
Age, Continuous	67.76 years STANDARD_DEVIATION 7.79 • n=5 Participants	68.40 years STANDARD_DEVIATION 8.04 • n=7 Participants	68.07 years STANDARD_DEVIATION 7.91 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=5 Participants	93 Participants n=7 Participants	190 Participants n=5 Participants
Age, Categorical >=65 years	78 Participants n=5 Participants	74 Participants n=7 Participants	152 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	8 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	153 Participants n=5 Participants	159 Participants n=7 Participants	312 Participants n=5 Participants
Region of Enrollment Korea, Republic of	175 participants n=5 Participants	167 participants n=7 Participants	342 participants n=5 Participants

PRIMARY outcome

Timeframe: 10days

Population: Per protocol population

Outcome measures

Outcome measures
Measure	DW224 n=143 Participants Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days	Avelox n=131 Participants Moxifloxacin 400mg tablet P.O. once daily for 7 days
Clinical Response in the Clinical Populations	86.71 percentage of participants Interval 81.15 to 92.28	86.26 percentage of participants Interval 80.36 to 92.16

SECONDARY outcome

Timeframe: 36days

Population: Per protocol 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.

Outcome measures

Outcome measures
Measure	DW224 n=143 Participants Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days	Avelox n=131 Participants Moxifloxacin 400mg tablet P.O. once daily for 7 days
Clinical Response in the Clinical Population	76.22 percentage of participants Interval 69.25 to 83.2	70.99 percentage of participants Interval 63.22 to 78.76

SECONDARY outcome

Timeframe: 10days

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.

Outcome measures

Outcome measures
Measure	DW224 n=43 Participants Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days	Avelox n=39 Participants Moxifloxacin 400mg tablet P.O. once daily for 7 days
Clinical Cure Rate in the Microbiological Per Protocol(PP) Population	88.37 Percentage of participants Interval 78.79 to 97.95	94.87 Percentage of participants Interval 87.95 to 100.0

SECONDARY outcome

Timeframe: 10days

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.

Outcome measures

Outcome measures
Measure	DW224 n=43 Participants Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days	Avelox n=39 Participants Moxifloxacin 400mg tablet P.O. once daily for 7 days
Microbiological Response Rate	67.44 Percentage of participants Interval 53.44 to 81.45	79.49 Percentage of participants Interval 66.81 to 92.16

SECONDARY outcome

Timeframe: 10 days

Population: Per protocol population

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.

Outcome measures

Outcome measures
Measure	DW224 n=141 Participants Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days	Avelox n=130 Participants Moxifloxacin 400mg tablet P.O. once daily for 7 days
Change in EXACT-PRO Score	-6.90 scores on a scale Standard Deviation 9.59	-4.29 scores on a scale Standard Deviation 9.72

SECONDARY outcome

Timeframe: 10 days

Population: Per protocol population

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.

Outcome measures

Outcome measures
Measure	DW224 n=139 Participants Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days	Avelox n=130 Participants Moxifloxacin 400mg tablet P.O. once daily for 7 days
Change in CAT Scores	-4.46 scores on a scale Standard Deviation 5.88	-2.48 scores on a scale Standard Deviation 5.96

Adverse Events

DW224

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Avelox

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DW224 n=175 participants at risk Zabofloxacin Tablet 400mg given by oral administration Moxifloxacin Tablet 400mg: multiple-dose	Avelox n=167 participants at risk Moxifloxacin Tablet 400mg given by oral administration Zabofloxacin Tablet 400mg: multiple-dose
Gastrointestinal disorders Nausea	1.7% 3/175 • Number of events 3 • About 1.5 years	2.4% 4/167 • Number of events 4 • About 1.5 years
Gastrointestinal disorders Dry mouth	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Gastrointestinal disorders Diarrhoea	2.3% 4/175 • Number of events 4 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Gastrointestinal disorders Dyspepsia	0.57% 1/175 • Number of events 1 • About 1.5 years	0.00% 0/167 • About 1.5 years
Gastrointestinal disorders Vimiting	0.57% 1/175 • Number of events 1 • About 1.5 years	0.00% 0/167 • About 1.5 years
Gastrointestinal disorders Abdominal discomfort	0.57% 1/175 • Number of events 1 • About 1.5 years	0.00% 0/167 • About 1.5 years
Gastrointestinal disorders Abdominal pain	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Gastrointestinal disorders Epigastric discomfort	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Gastrointestinal disorders Stomatitis	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Respiratory, thoracic and mediastinal disorders COPD	0.57% 1/175 • Number of events 1 • About 1.5 years	0.00% 0/167 • About 1.5 years
Respiratory, thoracic and mediastinal disorders Sputum retention	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Nervous system disorders Dizziness	1.7% 3/175 • Number of events 3 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Nervous system disorders Headache	0.57% 1/175 • Number of events 1 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Nervous system disorders Tremor	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Nervous system disorders Paraesthesia	0.57% 1/175 • Number of events 1 • About 1.5 years	0.00% 0/167 • About 1.5 years
Nervous system disorders Somnolence	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
General disorders Chest discomfort	1.1% 2/175 • Number of events 2 • About 1.5 years	0.00% 0/167 • About 1.5 years
General disorders Face oedema	0.57% 1/175 • Number of events 1 • About 1.5 years	0.00% 0/167 • About 1.5 years
General disorders Fatigue	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
General disorders Oedema peripheral	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Infections and infestations Nasopharyngitis	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Investigations Glucose urine present	0.57% 1/175 • Number of events 1 • About 1.5 years	0.00% 0/167 • About 1.5 years
Investigations Red blood cell microcytes present	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Skin and subcutaneous tissue disorders Pruritus	0.57% 1/175 • Number of events 1 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Skin and subcutaneous tissue disorders Rash	0.57% 1/175 • Number of events 1 • About 1.5 years	0.00% 0/167 • About 1.5 years
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Skin and subcutaneous tissue disorders Erythema	0.57% 1/175 • Number of events 1 • About 1.5 years	0.00% 0/167 • About 1.5 years
Cardiac disorders Palpitations	0.57% 1/175 • Number of events 1 • About 1.5 years	0.00% 0/167 • About 1.5 years
Renal and urinary disorders Haematuria	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Musculoskeletal and connective tissue disorders Flank pain	0.57% 1/175 • Number of events 1 • About 1.5 years	0.00% 0/167 • About 1.5 years
Eye disorders Vision blurred	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years
Vascular disorders Flushing	0.00% 0/175 • About 1.5 years	0.60% 1/167 • Number of events 1 • About 1.5 years

Additional Information

Principal Investigator

Asan Midical Center

Phone: +82-2-3010-3136

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60