The Clinical Trial to Evaluate the Efficacy and Safety of CKD-497
A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-497
1 other identifier
interventional
220
1 country
15
Brief Summary
To evaluate the efficacy and safety of CKD-497
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2018
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2018
CompletedFirst Submitted
Initial submission to the registry
October 30, 2018
CompletedFirst Posted
Study publicly available on registry
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2019
CompletedFebruary 6, 2020
November 1, 2018
10 months
October 30, 2018
February 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
BSS(Bronchitis Severity Score)
0(absent) \~ 4(very severe), Total Score: 0\~20
1 week
SUM8(The 8-symptom related questions in the Daily Cough and Phlegm)
0(Never) \~ 4(always), Total Score: 0\~32
1 week
Study Arms (4)
CKD-497 200mg
EXPERIMENTALCKD-497 200mg
CKD-497 300mg
EXPERIMENTALCKD-497 300mg
Active Comparator
ACTIVE COMPARATORcompartor
Placebo
PLACEBO COMPARATORCKD-497 placebo and comparator placebo
Interventions
Eligibility Criteria
You may qualify if:
- ≤ age \< 75
- Subject with acute upper respiratory infection and acute bronchitis infection
- Subject who agreeds to participate in this clinical trial voluntarily
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Ulsan University Hospital
Ulsan, Dong-gu, South Korea
KyungHee University Medical Center
Seoul, Dongdaemun-gu, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Dongjak-gu, South Korea
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Konkuk University Medical Center
Seoul, Gwangjin-gu, South Korea
Hanyang University Guri Hospital
Guri-si, Gyenggi-do, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Kangbuk Samsung Hospital
Seoul, Jongno-gu, South Korea
Kangdong Sacred Heart Hospital
Seoul, Kangdong-gu, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-gu, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, Seocho-gu, South Korea
Korea University Anam hospital
Seoul, Seongbuk-gu, South Korea
EWHA Womans University Mokdong Hospital
Seoul, Yangcheon-gu, South Korea
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, Yeongdeungpo-gu, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2018
First Posted
November 1, 2018
Study Start
May 29, 2018
Primary Completion
March 21, 2019
Study Completion
March 21, 2019
Last Updated
February 6, 2020
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share