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Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis

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

NCT02637310•PharmaKing

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - 75 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Key Dates

Start Date

December 1, 2015

Primary Completion Date

March 1, 2016

Completion Date

March 1, 2016

Last Updated

March 30, 2016

Enrollment

108

ACTUAL participants

Conditions

Acute Bronchitis

Interventions

N02RS1 1200mg

DRUG

Placebo

DRUG

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Acute Bronchitis

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COMPLETEDPHASE3

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COMPLETEDNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis

Inclusion Criteria

Exclusion Criteria

To Evaluate the Efficacy and Safety of ALC-2203 in Patients With Acute Bronchitis

A Study to Evaluate the Efficacy and Safety of DW5121 Compared to DW51211 and DW51212

Treatment of Adults With Acute Bronchitis in the Primary Healthcare Setting

Effectiveness of Antitussives, Anticholinergics and Honey Versus Usual Care in Adults With Acute Bronchitis.

Efficacy and Safety of Intramuscular Injection of Xiyanping Injection in the Treatment of Acute Bronchitis in Children

The Development and Testing of a Scaling Strategy for a Community-Based Primary Care Antimicrobial Stewardship Program