Clinical Trial: Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Double-blind, A Multicenter, Randomized, Placebo-controlled, Parallel, Phase 2 Study to Comparative Evaluate the Efficacy of N02RS1 600mg/Day, 12,00mg/Day in Korean Patients With Acute and
Brief Summary: 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.
Detailed Summary:
Sponsor: PharmaKing
Current Primary Outcome: Safety [ Time Frame: 12weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Efficacy [ Time Frame: 12weeks ]
- Before and after physical examination
- Before and after bital Sign: blood pressure, pulse rate, temperature.
- Before and after Lanza Score at the duodenum and stomach
- Lab: hematologic examination, blood coagulation examination,urine examination
- Cumulative incidence rate of an endoscopic peptic ulcer.
Original Secondary Outcome: Same as current
Information By: PharmaKing
Dates:
Date Received: October 31, 2013
Date Started: November 2013
Date Completion:
Last Updated: May 29, 2014
Last Verified: May 2014