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

NCT ID: NCT03726853

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-29

Study Completion Date

2019-03-21

Brief Summary

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To evaluate the efficacy and safety of CKD-497

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Detailed Description

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Conditions

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Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CKD-497 200mg

CKD-497 200mg

Group Type EXPERIMENTAL

CKD-497 200mg

Intervention Type DRUG

CKD-497 200mg

Comparator placebo

Intervention Type DRUG

Comparator placebo

CKD-497 300mg

CKD-497 300mg

Group Type EXPERIMENTAL

CKD-497 300mg

Intervention Type DRUG

CKD-497 300mg

Comparator placebo

Intervention Type DRUG

Comparator placebo

Active Comparator

compartor

Group Type ACTIVE_COMPARATOR

CKD-497 placebo

Intervention Type DRUG

Placebo of CKD-497

Comparator

Intervention Type DRUG

Comparator

Placebo

CKD-497 placebo and comparator placebo

Group Type PLACEBO_COMPARATOR

CKD-497 placebo

Intervention Type DRUG

Placebo of CKD-497

Comparator placebo

Intervention Type DRUG

Comparator placebo

Interventions

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CKD-497 200mg

CKD-497 200mg

Intervention Type DRUG

CKD-497 300mg

CKD-497 300mg

Intervention Type DRUG

CKD-497 placebo

Placebo of CKD-497

Intervention Type DRUG

Comparator

Comparator

Intervention Type DRUG

Comparator placebo

Comparator placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ulsan University Hospital

Ulsan, Dong-gu, South Korea

Site Status

KyungHee University Medical Center

Seoul, Dongdaemun-gu, South Korea

Site Status

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, Dongjak-gu, South Korea

Site Status

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Site Status

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status

Konkuk University Medical Center

Seoul, Gwangjin-gu, South Korea

Site Status

Hanyang University Guri Hospital

Guri-si, Gyenggi-do, South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Site Status

Kangbuk Samsung Hospital

Seoul, Jongno-gu, South Korea

Site Status

Kangdong Sacred Heart Hospital

Seoul, Kangdong-gu, South Korea

Site Status

Gachon University Gil Medical Center

Incheon, Namdong-gu, South Korea

Site Status

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, Seocho-gu, South Korea

Site Status

Korea University Anam hospital

Seoul, Seongbuk-gu, South Korea

Site Status

EWHA Womans University Mokdong Hospital

Seoul, Yangcheon-gu, South Korea

Site Status

The Catholic University of Korea, Yeouido ST. Mary's Hospital

Seoul, Yeongdeungpo-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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176AURI/AB17014

Identifier Type: -

Identifier Source: org_study_id

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