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

Acute Bronchitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637310
• Other study ID #: PMK-N02RS1_Phase 2B
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2015
• Last updated: March 29, 2016
• Start date: December 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: PharmaKing
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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.

• Patients taking other clinical trail's medicines within 30 days.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Disease
• Bronchitis

Intervention

Drug:
• N02RS1 1200mg
1200mg/day, Three times a day orally, 2 tablets once, 7 days
• Placebo
1200mg/day, Three times a day orally, 2 tablets once, 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PharmaKing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days		Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days)	Yes