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

Last updated: February 3, 2020
Sponsor: Hanmi Pharmaceutical Company Limited
Overall Status: Active - Recruiting

Phase

4

Condition

Bronchitis (Pediatric)

Bronchitis

Respiratory Syncytial Virus (Rsv) Infection

Treatment

N/A

Clinical Study ID

NCT04252963
HM-MUC-401
  • Ages > 19
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients with high fever (≥39℃)

  • Patients with severe respiratory diseases (ex) bronchial asthma, pneumonia, pulmonarytuberculosis, 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 thannormal upper range)

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

Study Design

Total Participants: 346
Study Start date:
November 02, 2018
Estimated Completion Date:
May 31, 2021

Study Description

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

Connect with a study center

  • Konkuk University Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.