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

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ClinicalTrials.gov Identifier: NCT03726853
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 9, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019
Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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


Contacts
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Contact: Dasom Kim 82-3149-7993 dasom@ckdpharm.com

Locations
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Korea, Republic of
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 27376
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
More Information
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03726853     History of Changes
Other Study ID Numbers: 176AURI/AB17014
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 12, 2018
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