The Clinical Trial to Evaluate the Efficacy and Safety of CKD-497
- Conditions
- Respiratory Infection
- Interventions
- Drug: CKD-497 200mgDrug: CKD-497 300mgDrug: CKD-497 placeboDrug: Comparator placeboDrug: Comparator
- Registration Number
- NCT03726853
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- Brief Summary
To evaluate the efficacy and safety of CKD-497
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- 19 ≤ age < 75
- Subject with acute upper respiratory infection and acute bronchitis infection
- Subject who agreeds to participate in this clinical trial voluntarily
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CKD-497 200mg CKD-497 200mg CKD-497 200mg CKD-497 200mg Comparator placebo CKD-497 200mg CKD-497 300mg CKD-497 300mg CKD-497 300mg CKD-497 300mg Comparator placebo CKD-497 300mg Active Comparator CKD-497 placebo compartor Active Comparator Comparator compartor Placebo CKD-497 placebo CKD-497 placebo and comparator placebo Placebo Comparator placebo CKD-497 placebo and comparator placebo
- Primary Outcome Measures
Name Time Method BSS(Bronchitis Severity Score) 1 week 0(absent) \~ 4(very severe), Total Score: 0\~20
SUM8(The 8-symptom related questions in the Daily Cough and Phlegm) 1 week 0(Never) \~ 4(always), Total Score: 0\~32
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Korea University Anam hospital
🇰🇷Seoul, Seongbuk-gu, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Gyeonggi-do, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Kangdong-gu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Namdong-gu, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Dong-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
Konkuk University Medical Center
🇰🇷Seoul, Gwangjin-gu, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Gangwon-do, Korea, Republic of
Hallym University Chuncheon Sacred Heart Hospital
🇰🇷Chuncheon, Gangwon-do, Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital
🇰🇷Seoul, Seocho-gu, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri, Gyenggi-do, Korea, Republic of
EWHA Womans University Mokdong Hospital
🇰🇷Seoul, Yangcheon-gu, Korea, Republic of
The Catholic University of Korea, Yeouido ST. Mary's Hospital
🇰🇷Seoul, Yeongdeungpo-gu, Korea, Republic of