The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With acute and acute exacerbation of chronic bronchitis for 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
102
600 mg/ day or 1200 mg/ day for 7 days
Seoul Nat'l University of Boramae Hospital
Seoul, Seoul, South Korea
Safety
1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.
Time frame: 12weeks
Efficacy
1. Before and after physical examination 2. Before and after bital Sign: blood pressure, pulse rate, temperature. 3. Before and after Lanza Score at the duodenum and stomach 4. Lab: hematologic examination, blood coagulation examination,urine examination 5. Cumulative incidence rate of an endoscopic peptic ulcer.
Time frame: 12weeks
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