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

Phase 2

Completed

• Conditions: Respiratory Infection
• Interventions: Drug: CKD-497 200mg; Drug: CKD-497 300mg; Drug: CKD-497 placebo; Drug: Comparator placebo; Drug: 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

Study Timeline

• Study Start: 2018-05-29
• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-30
• Status Verified: 2018-11
• Study First Posted: 2018-11-01
• Primary Completion: 2019-03-21
• Study Completion: 2019-03-21
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

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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

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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

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