NCT03726853CompletedPhase 2
A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-497
Chong Kun Dang Pharmaceutical15 sites in 1 country220 target enrollmentStarted: May 29, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 220
- Locations
- 15
- Primary Endpoint
- SUM8(The 8-symptom related questions in the Daily Cough and Phlegm)
Study Overview
Brief Summary
To evaluate the efficacy and safety of CKD-497
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
CKD-497 placebo and comparator placebo
Intervention: Comparator placebo (Drug)
CKD-497 200mg
Experimental
CKD-497 200mg
Intervention: CKD-497 200mg (Drug)
CKD-497 200mg
Experimental
CKD-497 200mg
Intervention: Comparator placebo (Drug)
CKD-497 300mg
Experimental
CKD-497 300mg
Intervention: CKD-497 300mg (Drug)
CKD-497 300mg
Experimental
CKD-497 300mg
Intervention: Comparator placebo (Drug)
Active Comparator
Active Comparator
compartor
Intervention: CKD-497 placebo (Drug)
Active Comparator
Active Comparator
compartor
Intervention: Comparator (Drug)
Placebo
Placebo Comparator
CKD-497 placebo and comparator placebo
Intervention: CKD-497 placebo (Drug)
Outcomes
Primary Outcomes
SUM8(The 8-symptom related questions in the Daily Cough and Phlegm)
Time Frame: 1 week
0(Never) \~ 4(always), Total Score: 0\~32
BSS(Bronchitis Severity Score)
Time Frame: 1 week
0(absent) \~ 4(very severe), Total Score: 0\~20
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (15)
Loading locations...
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