Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01658020 | A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg | PHASE3 | COMPLETED | 345 | — | — | Aug 1, 2012 | Aug 1, 2014 | Oct 13, 2014 | 1 | South Korea |
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.
| Arm | Type | Description |
|---|---|---|
| DW224 | EXPERIMENTAL | Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days |
| Avelox | ACTIVE_COMPARATOR | Moxifloxacin 400mg tablet P.O. once daily for 7days |
| Name | Type | Description |
|---|---|---|
| Zabofloxacin | DRUG | Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days |
| Moxifloxacin | DRUG | Moxifloxacin 400mg tablet P.O. once daily for 7days |
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 con...