Respiratory InfectionPhase 2NCT03726853
The Clinical Trial to Evaluate the Efficacy and Safety of CKD-497
A Phase 2 study testing CKD-497 200mg, CKD-497 300mg and Comparator in people with Respiratory Infection, run by Chong Kun Dang Pharmaceutical at 15 sites in South Korea.
Trial summary
To evaluate the efficacy and safety of CKD-497 Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Respiratory Infection
- What is being tested?
- CKD-497 200mg, CKD-497 300mg and Comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 29 May 2018to 21 Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 ≤ age < 75
- Subject with acute upper respiratory infection and acute bronchitis infection
- Subject who agreeds to participate in this clinical trial voluntarily
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do
Hanyang University Guri Hospital
Guri-si, Gyenggi-do
Gachon University Gil Medical Center
Incheon, Namdong-gu
KyungHee University Medical Center
Seoul, Dongdaemun-gu
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Dongjak-gu
Konkuk University Medical Center
Seoul, Gwangjin-gu
Kangbuk Samsung Hospital
Seoul, Jongno-gu
Kangdong Sacred Heart Hospital
Seoul, Kangdong-gu
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, Seocho-gu
Korea University Anam hospital
Seoul, Seongbuk-gu
EWHA Womans University Mokdong Hospital
Seoul, Yangcheon-gu
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, Yeongdeungpo-gu
Ulsan University Hospital
Ulsan, Dong-gu
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do
About this study
Official title: 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
- Conditions
- Respiratory Infection
- Being tested
- CKD-497 200mg, CKD-497 300mg, CKD-497 placebo, Comparator, Comparator placebo
- Keywords
- Acute upper respiratory infection, Acute bronchitis
- Medical subject headings
- Respiratory Tract Infections, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-497 200mgDrug
CKD-497 200mg
CKD-497 300mgDrug
CKD-497 300mg
CKD-497 placeboDrug
Placebo of CKD-497
ComparatorDrug
Comparator
Comparator placeboDrug
Comparator placebo
| Study group | Role | What they receive |
|---|---|---|
| CKD-497 200mg | Experimental | CKD-497 200mg Receives: Drug: CKD-497 200mg; Drug: Comparator placebo |
| CKD-497 300mg | Experimental | CKD-497 300mg Receives: Drug: CKD-497 300mg; Drug: Comparator placebo |
| Active Comparator | Active comparator | compartor Receives: Drug: CKD-497 placebo; Drug: Comparator |
| Placebo | Placebo comparator | CKD-497 placebo and comparator placebo Receives: Drug: CKD-497 placebo; Drug: Comparator placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSS(Bronchitis Severity Score)
0(absent) ~ 4(very severe), Total Score: 0~20
Measured: 1 week
SUM8(The 8-symptom related questions in the Daily Cough and Phlegm)
0(Never) ~ 4(always), Total Score: 0~32
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start29 May 2018
- Primary completion21 Mar 2019
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726853
- Sponsor's protocol ID
- 176AURI/AB17014
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2018
- Last updated
- 6 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-497
- ClinicalTrials.gov ID
- NCT03726853
- Acronym / sponsor ID
- 176AURI/AB17014
- Conditions
- Respiratory Infection
- Keywords
- Acute upper respiratory infection, Acute bronchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of CKD-497
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CKD-497 200mg | Experimental | Drug: CKD-497 200mg, Drug: Comparator placeboCKD-497 200mg |
| CKD-497 300mg | Experimental | Drug: CKD-497 300mg, Drug: Comparator placeboCKD-497 300mg |
| Active Comparator | Active comparator | Drug: CKD-497 placebo, Drug: Comparatorcompartor |
| Placebo | Placebo comparator | Drug: CKD-497 placebo, Drug: Comparator placeboCKD-497 placebo and comparator placebo |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 ≤ age < 75
- Subject with acute upper respiratory infection and acute bronchitis infection
- Subject who agreeds to participate in this clinical trial voluntarily
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD-497 200mgCKD-497 200mg | Drug | CKD-497 200mg |
| CKD-497 300mgCKD-497 300mg | Drug | CKD-497 300mg |
| CKD-497 placeboPlacebo of CKD-497 | Drug | Active Comparator, Placebo |
| ComparatorComparator | Drug | Active Comparator |
| Comparator placeboComparator placebo | Drug | CKD-497 200mg, CKD-497 300mg, Placebo |
Primary outcome
BSS(Bronchitis Severity Score)
Time frame: 1 week
0(absent) ~ 4(very severe), Total Score: 0~20
SUM8(The 8-symptom related questions in the Daily Cough and Phlegm)
Time frame: 1 week
0(Never) ~ 4(always), Total Score: 0~32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CKD-497 200mg, CKD-497 300mg and Comparator in people with Respiratory Infection, run by Chong Kun Dang Pharmaceutical at 15 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BSS(Bronchitis Severity Score) (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.