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NCT03726853 Clinical Trial

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

Respiratory Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03726853
Other study ID # 176AURI/AB17014
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 29, 2018
Est. completion date March 21, 2019

Study information
Verified date November 2018
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of CKD-497

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date March 21, 2019
Est. primary completion date March 21, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility Inclusion Criteria:

1. 19 = age < 75

2. Subject with acute upper respiratory infection and acute bronchitis infection

3. Subject who agreeds to participate in this clinical trial voluntarily

Exclusion Criteria:

1. Subject who need antibiotics treatment during the clinical trial

2. 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

3. Subject who cannot participate in a clinical trial based on the PI's judgment

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CKD-497 200mg
CKD-497 200mg
• CKD-497 300mg
CKD-497 300mg
• CKD-497 placebo
Placebo of CKD-497
• Comparator
Comparator
• Comparator placebo
Comparator placebo

Locations
Country Name City State
Korea, Republic of Hallym University Sacred Heart Hospital Anyang Gyeonggi-do
Korea, Republic of Hallym University Chuncheon Sacred Heart Hospital Chuncheon Gangwon-do
Korea, Republic of Hanyang University Guri Hospital Guri Gyenggi-do
Korea, Republic of Gachon University Gil Medical Center Incheon Namdong-gu
Korea, Republic of EWHA Womans University Mokdong Hospital Seoul Yangcheon-gu
Korea, Republic of Kangbuk Samsung Hospital Seoul Jongno-gu
Korea, Republic of Kangdong Sacred Heart Hospital Seoul Kangdong-gu
Korea, Republic of Konkuk University Medical Center Seoul Gwangjin-gu
Korea, Republic of Korea University Anam hospital Seoul Seongbuk-gu
Korea, Republic of KyungHee University Medical Center Seoul Dongdaemun-gu
Korea, Republic of Seoul Metropolitan Government Seoul National University Boramae Medical Center Seoul Dongjak-gu
Korea, Republic of The Catholic University of Korea, Seoul ST. Mary's Hospital Seoul Seocho-gu
Korea, Republic of The Catholic University of Korea, Yeouido ST. Mary's Hospital Seoul Yeongdeungpo-gu
Korea, Republic of Ulsan University Hospital Ulsan Dong-gu
Korea, Republic of Wonju Severance Christian Hospital Wonju Gangwon-do

Sponsors (1)
Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary BSS(Bronchitis Severity Score) 0(absent) ~ 4(very severe), Total Score: 0~20 1 week
Primary SUM8(The 8-symptom related questions in the Daily Cough and Phlegm) 0(Never) ~ 4(always), Total Score: 0~32 1 week
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