Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PharmaKing
ClinicalTrials.gov Identifier:
NCT01979926
First received: October 31, 2013
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Acute Exacerbation of Chronic Bronchitis
Drug: Combination of Broussonetia spp and Lonicera spp
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Chronic Bronchitis

Resource links provided by NLM:


Further study details as provided by PharmaKing:

Primary Outcome Measures:
  • Safety [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
    1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 102
Study Start Date: November 2013
Study Completion Date: March 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N02RS1 200mg
Combination of Broussonetia spp and Lonicera spp
Drug: Combination of Broussonetia spp and Lonicera spp
600 mg/ day or 1200 mg/ day for 7 days
Other Name: N02RS1
Experimental: N02RS1 400mg
Combination of Broussonetia spp and Lonicera spp
Drug: Combination of Broussonetia spp and Lonicera spp
600 mg/ day or 1200 mg/ day for 7 days
Other Name: N02RS1
Placebo Comparator: Placebo
Sugar pill
Drug: Combination of Broussonetia spp and Lonicera spp
600 mg/ day or 1200 mg/ day for 7 days
Other Name: N02RS1

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979926

Locations
Korea, Republic of
Seoul Nat'l University of Boramae Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
PharmaKing
Investigators
Study Director: Wayne B An, Bs Korea Pharmaceutical Manufacturers Association
  More Information

No publications provided

Responsible Party: PharmaKing
ClinicalTrials.gov Identifier: NCT01979926     History of Changes
Other Study ID Numbers: PMK-N02RS1
Study First Received: October 31, 2013
Last Updated: May 29, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on July 23, 2014