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

Primary Purpose

Respiratory Infection

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-497 200mg
CKD-497 300mg
CKD-497 placebo
Comparator
Comparator placebo
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Infection focused on measuring Acute upper respiratory infection, Acute bronchitis

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ulsan University Hospital
  • KyungHee University Medical Center
  • Seoul Metropolitan Government Seoul National University Boramae Medical Center
  • Hallym University Chuncheon Sacred Heart Hospital
  • Wonju Severance Christian Hospital
  • Konkuk University Medical Center
  • Hanyang University Guri Hospital
  • Hallym University Sacred Heart Hospital
  • Kangbuk Samsung Hospital
  • Kangdong Sacred Heart Hospital
  • Gachon University Gil Medical Center
  • The Catholic University of Korea, Seoul ST. Mary's Hospital
  • Korea University Anam hospital
  • EWHA Womans University Mokdong Hospital
  • The Catholic University of Korea, Yeouido ST. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

CKD-497 200mg

CKD-497 300mg

Active Comparator

Placebo

Arm Description

CKD-497 200mg

CKD-497 300mg

compartor

CKD-497 placebo and comparator placebo

Outcomes

Primary Outcome Measures

BSS(Bronchitis Severity Score)
0(absent) ~ 4(very severe), Total Score: 0~20
SUM8(The 8-symptom related questions in the Daily Cough and Phlegm)
0(Never) ~ 4(always), Total Score: 0~32

Secondary Outcome Measures

Full Information

First Posted
October 30, 2018
Last Updated
February 5, 2020
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03726853
Brief Title
The Clinical Trial to Evaluate the Efficacy and Safety of CKD-497
Official Title
A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-497
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
March 21, 2019 (Actual)
Study Completion Date
March 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the efficacy and safety of CKD-497

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infection
Keywords
Acute upper respiratory infection, Acute bronchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CKD-497 200mg
Arm Type
Experimental
Arm Description
CKD-497 200mg
Arm Title
CKD-497 300mg
Arm Type
Experimental
Arm Description
CKD-497 300mg
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
compartor
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
CKD-497 placebo and comparator placebo
Intervention Type
Drug
Intervention Name(s)
CKD-497 200mg
Intervention Description
CKD-497 200mg
Intervention Type
Drug
Intervention Name(s)
CKD-497 300mg
Intervention Description
CKD-497 300mg
Intervention Type
Drug
Intervention Name(s)
CKD-497 placebo
Intervention Description
Placebo of CKD-497
Intervention Type
Drug
Intervention Name(s)
Comparator
Intervention Description
Comparator
Intervention Type
Drug
Intervention Name(s)
Comparator placebo
Intervention Description
Comparator placebo
Primary Outcome Measure Information:
Title
BSS(Bronchitis Severity Score)
Description
0(absent) ~ 4(very severe), Total Score: 0~20
Time Frame
1 week
Title
SUM8(The 8-symptom related questions in the Daily Cough and Phlegm)
Description
0(Never) ~ 4(always), Total Score: 0~32
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ulsan University Hospital
City
Ulsan
State/Province
Dong-gu
Country
Korea, Republic of
Facility Name
KyungHee University Medical Center
City
Seoul
State/Province
Dongdaemun-gu
Country
Korea, Republic of
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
State/Province
Dongjak-gu
Country
Korea, Republic of
Facility Name
Hallym University Chuncheon Sacred Heart Hospital
City
Chuncheon
State/Province
Gangwon-do
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wonju
State/Province
Gangwon-do
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
State/Province
Gwangjin-gu
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri
State/Province
Gyenggi-do
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
State/Province
Jongno-gu
Country
Korea, Republic of
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
State/Province
Kangdong-gu
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
State/Province
Namdong-gu
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital
City
Seoul
State/Province
Seocho-gu
Country
Korea, Republic of
Facility Name
Korea University Anam hospital
City
Seoul
State/Province
Seongbuk-gu
Country
Korea, Republic of
Facility Name
EWHA Womans University Mokdong Hospital
City
Seoul
State/Province
Yangcheon-gu
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Yeouido ST. Mary's Hospital
City
Seoul
State/Province
Yeongdeungpo-gu
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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