A Multi Center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of N02RS1 in Patients With Acute Bronchitis

PharmaKing0 sites108 target enrollmentDecember 2015

ConditionsAcute Bronchitis

InterventionsN02RS1 1200mg Placebo

DrugsN02RS1 1200mg Placebo

Overview

Phase: Phase 2
Intervention: N02RS1 1200mg
Conditions: Acute Bronchitis
Sponsor: PharmaKing
Enrollment: 108
Primary Endpoint: BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis

Detailed Description

Suitable subjects randomized to the experimental or control group. The subjects eat IP during 7days. Visit 3(3 days) evaluate BSS through phone call and visit 4(8 days) evaluate efficacy and safety.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

March 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

PharmaKing

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients over 19, under 75 of age
•Patients acute bronchitis, sputum symptoms, BSS over 7 points.
•Patients acute bronchitis within 7days.
•Non-pregnant, patients who agree to contraception.
•Patients who can write diary and available to communicate.
•Patients voluntarily agreed

Exclusion Criteria

•Patients with hypersensitivity to the drug.
•Patients who have gotten systemic steroid treatment within 4 weeks.
•Patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days.
•Patients who have gotten treatment of mucus solvents or antitussives within 3 days.
•Patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease.
•Patients heart disease, severe kidney, liver disease.
•The bleeding tendency or immunosuppressed patients.
•Patients with clinically significant abnormal values.
•Pregnant women or nursing mothers.
•Patients alcoholics or drug abuse.