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OpenTrials
Completed

NCT Number: NCT03726853

The Clinical Trial to Evaluate the Efficacy and Safety of CKD-497

To evaluate the efficacy and safety of CKD-497

Completed

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Key information

Conditions

Respiratory Infection Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ulsan University Hospital, Ulsan, Dong-gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 19 ≤ age < 75
  • Subject with acute upper respiratory infection and acute bronchitis infection
  • Subject who agreeds to participate in this clinical trial voluntarily

Exclusion criteria

  • Subject who need antibiotics treatment during the clinical trial
  • Subject suffering from severe respiratory diseases such as pneumonia, asthma, chronic closed lung diseases (COPD), tuberculosis, bronchial enlargement, malignant tumors in the lungs, and chronic bronchitis during screening
  • Subject who cannot participate in a clinical trial based on the PI's judgment

Treatment and study plan

CKD-497 200mg

Drug

CKD-497 200mg

CKD-497 300mg

Drug

CKD-497 300mg

CKD-497 placebo

Drug

Placebo of CKD-497

Comparator

Drug

Comparator

Comparator placebo

Drug

Comparator placebo

Primary outcomes

  1. BSS(Bronchitis Severity Score)

    Time frame: 1 week

    0(absent) ~ 4(very severe), Total Score: 0~20

  2. SUM8(The 8-symptom related questions in the Daily Cough and Phlegm)

    Time frame: 1 week

    0(Never) ~ 4(always), Total Score: 0~32

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-497

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2018
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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