GastritisPhase 3NCT04255589
A Clinical Trial to Evaluate the Efficacy and Safety of CKD-495
A Phase 3 study testing CKD-495 75mg and Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg in people with Gastritis, run by Chong Kun Dang Pharmaceutical at 17 sites in South Korea.
Trial summary
To Evaluate the Efficacy and Safety of CKD-495 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastritis
- What is being tested?
- CKD-495 75mg and Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 17 sitesSouth Korea
- Study dates
- 6 Jan 2020to 20 May 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female subjects aged ≥ 19
- Acute or Chronic gastritis patients who have more than 1 erosion on endoscopy within 7days prior to the use of the Investigator's Product taken date
- Patients who have more than 1 subjective symptom
Who cannot join
- Patients with peptic ulcer, gastroesophageal reflux disease, malignant tumor in the digestive system or coagulation disorder, or taking antithrombotic medicine
- Patients who have been taken any gastritis medicine that could affect the treatment: H2 receptor antagonist, PPI(Proton Pump Inhibitor), antacid, improvement of movement in digestive system, Prostaglandin, and protective agent for gastritis
- Patients who have to take medicine that could cause gastritis
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
South Korea17 sites
Busan National University Hospital
Busan, Seo-gu
Inje University Busan Paik Hospital
Busan
Kyoungpook National University Hospital
Daegu, Gyeongsangbuk-do
Yeungnam University Medical Center
Daegu
Chonnam National University Hospital
Gwangju, Donggu
Chonbuk National University Hospital
Jeonju
Seoul National University Bundang Hospital
Seongnam
Chung Ang University Hospital
Seoul
Hanyang University Medical Center
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
Yeouido ST. Mary's Hospital
Seoul
About this study
Official title: A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients With Acute and Chronic Gastritis
To Evaluate the Efficacy and Safety of CKD-495
Read the detailed description
A phase 3, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients With Acute and Chronic Gastritis
- Conditions
- Gastritis
- Being tested
- CKD-495 75mg, Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg, Placebo of the CKD-495 75mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg
- Keywords
- Acute Gastritis, Chronic Gastritis, Cinnamic acid, CKD-495
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-495 75mgDrug
CKD-495 75mg Tab.
Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mgDrug
Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.
Placebo of the CKD-495 75mgDrug
Placebo of the CKD-495 75mg Tab.
Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mgDrug
Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients assigned to this group are treated with one CKD-495 75mg Tab.,and one Placebo Tab.(Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab) Receives: Drug: CKD-495 75mg; Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg |
| Active comparator Group | Active comparator | Patients assigned to this group are treated with one Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab, and one Placebo Tab.(Placebo of the CKD-495 75mg) Receives: Drug: Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Drug: Placebo of the CKD-495 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate of gastric erosion
50% change on erosive grade
Measured: 14days after drug administrations
Secondary outcomes (5)
cure rate of gastric erosion
0 erosion
Measured: 14days after drug administrations
Improvement rate of symptoms
50% change on the Subjective Symptoms total score
Measured: 14days after drug administrations
Improvement rate of gastric edema
50% change on the Edema grade
Measured: 14days after drug administrations
Improvement rate of gastric erythema
50% change on the Erythema grade
Measured: 14days after drug administrations
Improvement rate of gastric hemorrhage
50% change on the Hemorrhage grade
Measured: 14days after drug administrations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start6 Jan 2020
- Primary completion20 May 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oh Young Lee, MD, Ph.D., Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255589
- Sponsor's protocol ID
- A74_02AG/CG1904
- Status last verified
- Jun 2021
- First submitted
- 3 Feb 2020
- Last updated
- 2 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seo SY, Lee ST, Kim SK, Chun HJ, Song GA, Lee DH, Kim JJ, Kim JI, Lee YC, Kim TN, Jee SR, Park SY, Kim JG, Park JJ, Kim SG, Park JM, Park JH, Park SJ, Lee OY. Efficacy and safety of CKD-495 in acute and chronic gastritis: A Phase III superiority clinical trial. Medicine (Baltimore). 2023 Dec 8;102(49):e35926. doi: 10.1097/MD.0000000000035926.
PubMed 38065906
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients With Acute and Chronic Gastritis
- ClinicalTrials.gov ID
- NCT04255589
- Acronym / sponsor ID
- A74_02AG/CG1904
- Conditions
- Gastritis
- Keywords
- Acute Gastritis, Chronic Gastritis, Cinnamic acid, CKD-495
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 5 Feb 2020 (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-495
Detailed description
A phase 3, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients With Acute and Chronic Gastritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: CKD-495 75mg, Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mgPatients assigned to this group are treated with one CKD-495 75mg Tab.,and one Placebo Tab.(Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab) |
| Active comparator Group | Active comparator | Drug: Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg, Drug: Placebo of the CKD-495 75mgPatients assigned to this group are treated with one Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab, and one Placebo Tab.(Placebo of the CKD-495 75mg) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female subjects aged ≥ 19
- Acute or Chronic gastritis patients who have more than 1 erosion on endoscopy within 7days prior to the use of the Investigator's Product taken date
- Patients who have more than 1 subjective symptom
Key exclusion criteria (3 listed)
- Patients with peptic ulcer, gastroesophageal reflux disease, malignant tumor in the digestive system or coagulation disorder, or taking antithrombotic medicine
- Patients who have been taken any gastritis medicine that could affect the treatment: H2 receptor antagonist, PPI(Proton Pump Inhibitor), antacid, improvement of movement in digestive system, Prostaglandin, and protective agent for gastritis
- Patients who have to take medicine that could cause gastritis
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-495 75mgCKD-495 75mg Tab. | Drug | Experimental Group |
| Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mgArtemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab. | Drug | Active comparator Group |
| Placebo of the CKD-495 75mgPlacebo of the CKD-495 75mg Tab. | Drug | Active comparator Group |
| Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mgPlacebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab. | Drug | Experimental Group |
Primary outcome
Improvement rate of gastric erosion
Time frame: 14days after drug administrations
50% change on erosive grade
5 secondary outcomes
cure rate of gastric erosion
Time frame: 14days after drug administrations
Improvement rate of symptoms
Time frame: 14days after drug administrations
Improvement rate of gastric edema
Time frame: 14days after drug administrations
Improvement rate of gastric erythema
Time frame: 14days after drug administrations
Improvement rate of gastric hemorrhage
Time frame: 14days after drug administrations
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 2 Jul 2021.
- Derived from this study: PubMed 38065906Seo SY, Lee ST, Kim SK, Chun HJ, Song GA, Lee DH, Kim JJ, Kim JI, Lee YC, Kim TN, Jee SR, Park SY, Kim JG, Park JJ, Kim SG, Park JM, Park JH, Park SJ, Lee OY. Efficacy and safety of CKD-495 in acute and chronic gastritis: A Phase III superiority clinical trial. Medicine (Baltimore). 2023 Dec 8;102(49):e35926. doi: 10.1097/MD.0000000000035926.
- 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.
Oh Young Lee, MD, Ph.D. principal investigator
Hanyang University
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CKD-495 75mg and Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg in people with Gastritis, run by Chong Kun Dang Pharmaceutical at 17 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 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Improvement rate of gastric erosion (time frame: 14days after drug administrations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04255589, which also lists 1 linked publication.
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 2 Jul 2021.