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OpenTrials
Completed

NCT Number: NCT01979926

Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis

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.

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Key information

Conditions

Acute Exacerbation of Chronic Bronchitis

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul Nat'l University of Boramae Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18, under 75 years of age
  • Patients Acute and Chronic Bronchitis

Exclusion criteria

  • Patients who have gotten a glucocorticoids treatment within 4 weeks.
  • Patients who need treatments of antibiotic and acute bronchitis infection.
  • Patients who have gotten teatments of antibiotic,bronchodilator,painkiller and secretagog within 7 days.
  • Bronchial asthma patient.
  • Patients who have an indication of bleeding.
  • Patients who have a serious heart and renal disease or liver ailment or immunosuppressive response.
  • Patients who have history of over 3 phage of Chronic obstructiv lung disease
  • Bronchiectasis patients.

Treatment and study plan

Combination of Broussonetia spp and Lonicera spp

Drug

600 mg/ day or 1200 mg/ day for 7 days

Other names: N02RS1

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

PharmaKing

Industry

Registry information

Official study 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 Chronic Bronchitis

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 8, 2013
Registry last updated
May 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.