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

Sponsor

Chong Kun Dang Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT03726853

Collaborator

(none)

220

Enrollment

Locations

Arms

9.7

Actual Duration (Months)

14.7

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Mar 21, 2019

Actual Study Completion Date :

Mar 21, 2019

Arms and Interventions

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

Primary Outcome Measures

BSS(Bronchitis Severity Score) [1 week]
0(absent) ~ 4(very severe), Total Score: 0~20
SUM8(The 8-symptom related questions in the Daily Cough and Phlegm) [1 week]
0(Never) ~ 4(always), Total Score: 0~32

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Ulsan University Hospital	Ulsan	Dong-gu	Korea, Republic of
2	KyungHee University Medical Center	Seoul	Dongdaemun-gu	Korea, Republic of
3	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul	Dongjak-gu	Korea, Republic of
4	Hallym University Chuncheon Sacred Heart Hospital	Chuncheon	Gangwon-do	Korea, Republic of
5	Wonju Severance Christian Hospital	Wonju	Gangwon-do	Korea, Republic of
6	Konkuk University Medical Center	Seoul	Gwangjin-gu	Korea, Republic of
7	Hanyang University Guri Hospital	Guri	Gyenggi-do	Korea, Republic of
8	Hallym University Sacred Heart Hospital	Anyang	Gyeonggi-do	Korea, Republic of
9	Kangbuk Samsung Hospital	Seoul	Jongno-gu	Korea, Republic of
10	Kangdong Sacred Heart Hospital	Seoul	Kangdong-gu	Korea, Republic of
11	Gachon University Gil Medical Center	Incheon	Namdong-gu	Korea, Republic of
12	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul	Seocho-gu	Korea, Republic of
13	Korea University Anam hospital	Seoul	Seongbuk-gu	Korea, Republic of
14	EWHA Womans University Mokdong Hospital	Seoul	Yangcheon-gu	Korea, Republic of
15	The Catholic University of Korea, Yeouido ST. Mary's Hospital	Seoul	Yeongdeungpo-gu	Korea, Republic of

Sponsors and Collaborators

Chong Kun Dang Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chong Kun Dang Pharmaceutical

ClinicalTrials.gov Identifier:

NCT03726853

Other Study ID Numbers:

176AURI/AB17014

First Posted:

Nov 1, 2018

Last Update Posted:

Feb 6, 2020

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chong Kun Dang Pharmaceutical

Acute upper respiratory infection

Acute bronchitis

Additional relevant MeSH terms:

Respiratory Tract Infections

Study Results

No Results Posted as of Feb 6, 2020