Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet(Streptokinase • Streptodornase)

• Status: Recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase 4 study to evaluate efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Streptokinase

Criteria

Inclusion Criteria:

• 19≤ age

• Patients with acute upper respiratory infection or acute bronchitis

• Patients with cough and phlegm within 48 hrs as of Visit 1

• Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

• Patients with high fever (≥39℃)

• Patients with severe respiratory diseases (ex) bronchial asthma, pneumonia, pulmonary tuberculosis, bronchiectasis, mucus sticking, chronic obstructive pulmonary disease (COPD), etc.

• Patients with a history of hypersensitivity to drug

• Patients with abnormal blood coagulation

• Patients with thrombocytopenia

• Patients with uncontrolled hypertension

• Patients with a severe liver disorder(AST or ALT level exceeds 2 times more than normal upper range)

• Patients woth a clinically significant renal failure(MDRD eGFP < 60 mL/min/1.73m2)