Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis

May 29, 2014 updated by: PharmaKing

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Sugar pill
Drug: Combination of Broussonetia spp and Lonicera spp
600 mg/ day or 1200 mg/ day for 7 days
Other Names:
  • N02RS1
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 Names:
  • 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 Names:
  • N02RS1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PharmaKing

Investigators

  • Study Director: Wayne B An, Bs, Korea Pharmaceutical Manufacturers Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (Estimate)

November 8, 2013

Study Record Updates

Last Update Posted (Estimate)

May 30, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMK-N02RS1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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