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Phase 2 Study of Zabofloxacin in Mild to Moderate Community-Acquired Pneumonia
KCT0001343Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2008
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- zabofloxacin
- Conditions
- community-acquired pneumonia (CAP)
01
Overview
Phase 2, randomised, double-blind trial of zabofloxacin in community-acquired pneumonia (CAP) (4 arms), sponsored by Dongwha Pharmaceutical Co., Ltd. Primary endpoints: Safety of zabofloxacin, Efficacy of zabofloxacin and 1 more. Started Nov 2008; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Zabofloxacin dosing regimen 1
Patients receive the first zabofloxacin dosing regimen for mild to moderate community-acquired pneumonia.
Zabofloxacin dosing regimen 2
Patients receive the second zabofloxacin dosing regimen for mild to moderate community-acquired pneumonia.
Zabofloxacin dosing regimen 3
Patients receive the third zabofloxacin dosing regimen for mild to moderate community-acquired pneumonia.
Active control (standard antibiotic therapy)
Patients receive a standard-of-care active comparator antibiotic for mild to moderate community-acquired pneumonia.
03
Who it enrols
Adult patients in South Korea with mild to moderate community-acquired pneumonia; healthy volunteers are not included.
04
Endpoints
Primary
Safety of zabofloxacin
Efficacy of zabofloxacin
Pharmacokinetic profile of zabofloxacin
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