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 ]

1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.


Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy [ Time Frame: 12weeks ]

  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.


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