Phase 3
Completed N=342
A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg
Source: ClinicalTrials.gov NCT01658020 ↗Enrolled (actual)
342
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Clinical Response in the Clinical Populations — 86.71; 86.26 percentage of participants
Summary
The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple dose of Zabofloxacin Tablet 400 mg.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response in the Clinical Populations |
86.71; 86.26 | — |
| SECONDARY Clinical Response in the Clinical Population |
76.22; 70.99 | — |
| SECONDARY Clinical Cure Rate in the Microbiological Per Protocol(PP) Population |
88.37; 94.87 | — |
| SECONDARY Microbiological Response Rate |
67.44; 79.49 | — |
| SECONDARY Change in EXACT-PRO Score |
-6.90; -4.29 | — |
| SECONDARY Change in CAT Scores |
-4.46; -2.48 | — |
Eligibility Criteria
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) 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 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
Data sourced from ClinicalTrials.gov (NCT01658020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.