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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726853
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Respiratory Infection Drug: CKD-497 200mg Drug: CKD-497 300mg Drug: CKD-497 placebo Drug: Comparator Drug: Comparator placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-497
Actual Study Start Date : May 29, 2018
Actual Primary Completion Date : March 21, 2019
Actual Study Completion Date : March 21, 2019

Arm Intervention/treatment
Experimental: CKD-497 200mg
CKD-497 200mg
Drug: CKD-497 200mg
CKD-497 200mg

Drug: Comparator placebo
Comparator placebo

Experimental: CKD-497 300mg
CKD-497 300mg
Drug: CKD-497 300mg
CKD-497 300mg

Drug: Comparator placebo
Comparator placebo

Active Comparator: Active Comparator
compartor
Drug: CKD-497 placebo
Placebo of CKD-497

Drug: Comparator
Comparator

Placebo Comparator: Placebo
CKD-497 placebo and comparator placebo
Drug: CKD-497 placebo
Placebo of CKD-497

Drug: Comparator placebo
Comparator placebo




Primary Outcome Measures :
  1. BSS(Bronchitis Severity Score) [ Time Frame: 1 week ]
    0(absent) ~ 4(very severe), Total Score: 0~20

  2. SUM8(The 8-symptom related questions in the Daily Cough and Phlegm) [ Time Frame: 1 week ]
    0(Never) ~ 4(always), Total Score: 0~32



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726853


Locations
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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
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, Korea, Republic of
Wonju Severance Christian Hospital
Wonju, Gangwon-do, Korea, Republic of
Konkuk University Medical Center
Seoul, Gwangjin-gu, Korea, Republic of
Hanyang University Guri Hospital
Guri, Gyenggi-do, Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Gyeonggi-do, Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Jongno-gu, Korea, Republic of
Kangdong Sacred Heart Hospital
Seoul, Kangdong-gu, Korea, Republic of
Gachon University Gil Medical Center
Incheon, Namdong-gu, Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, Seocho-gu, Korea, Republic of
Korea University Anam hospital
Seoul, Seongbuk-gu, 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
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03726853    
Other Study ID Numbers: 176AURI/AB17014
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chong Kun Dang Pharmaceutical:
Acute upper respiratory infection
Acute bronchitis
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases