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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-02

Study Completion Date

2021-05-31

Brief Summary

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

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Detailed Description

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Double-blind, randomized, placebo controlled, multicenter, phase 4 clinical trial to assess the efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase) in patients with acute upper respiratory infection or acute bronchitis

Conditions

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Acute Upper Respiratory Infection Acute Bronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mucolase

Group Type EXPERIMENTAL

MUCOLASE tablet (streptokinase • streptodornase)

Intervention Type DRUG

streptokinase • streptodornase 5mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo of MUCOLASE tablet

Interventions

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MUCOLASE tablet (streptokinase • streptodornase)

streptokinase • streptodornase 5mg

Intervention Type DRUG

Placebo

Placebo of MUCOLASE tablet

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No