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

To evaluate the efficacy and safety of CKD-497

Study Overview

• Status: Completed
• Conditions: Respiratory Infection
• Intervention / Treatment: Drug: CKD-497 200mg; Drug: Comparator placebo; Drug: CKD-497 300mg; Drug: CKD-497 placebo; Drug: Comparator

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dong-gu
    • Ulsan, Dong-gu, Korea, Republic of
      • Ulsan University Hospital
  • Dongdaemun-gu
    • Seoul, Dongdaemun-gu, Korea, Republic of
      • Kyunghee University Medical Center
  • Dongjak-gu
    • Seoul, Dongjak-gu, Korea, Republic of
      • Seoul Metropolitan Government Seoul National University Boramae Medical Center
  • Gangwon-do
    • Chuncheon, Gangwon-do, Korea, Republic of
      • Hallym University Chuncheon Sacred Heart Hospital
    • Wonju, Gangwon-do, Korea, Republic of
      • Wonju Severance Christian Hospital
  • Gwangjin-gu
    • Seoul, Gwangjin-gu, Korea, Republic of
      • Konkuk University Medical Center
  • Gyenggi-do
    • Guri, Gyenggi-do, Korea, Republic of
      • Hanyang University Guri Hospital
  • Gyeonggi-do
    • Anyang, Gyeonggi-do, Korea, Republic of
      • Hallym University Sacred Heart Hospital
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of
      • Kangbuk Samsung Hospital
  • Kangdong-gu
    • Seoul, Kangdong-gu, Korea, Republic of
      • Kangdong Sacred Heart Hospital
  • Namdong-gu
    • Incheon, Namdong-gu, Korea, Republic of
      • Gachon University Gil Medical Center
  • Seocho-gu
    • Seoul, Seocho-gu, Korea, Republic of
      • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seongbuk-gu
    • Seoul, Seongbuk-gu, Korea, Republic of
      • Korea University Anam Hospital
  • Yangcheon-gu
    • Seoul, Yangcheon-gu, Korea, Republic of
      • Ewha Womans University Mokdong Hospital
  • Yeongdeungpo-gu
    • Seoul, Yeongdeungpo-gu, Korea, Republic of
      • The Catholic University of Korea, Yeouido St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CKD-497 200mg	Drug: CKD-497 200mg; CKD-497 200mg; Drug: Comparator placebo; Comparator placebo
Experimental: CKD-497 300mg	Drug: Comparator placebo; Comparator placebo; Drug: CKD-497 300mg; CKD-497 300mg
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: Comparator placebo; Comparator placebo; Drug: CKD-497 placebo; Placebo of CKD-497

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2018
• Primary Completion (Actual): March 21, 2019
• Study Completion (Actual): March 21, 2019

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 5, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Acute bronchitis; Acute upper respiratory infection
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 176AURI/AB17014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No