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GastritisPhase 2NCT03437785

Clinical Trial to Evaluate the Efficacy and Safety of CKD-495 Tablet

A Phase 2 study testing CKD-495 75mg, CKD-495 150mg and Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg in people with Gastritis, run by Chong Kun Dang Pharmaceutical at 16 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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, CKD-495 150mg and Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
16 sitesSouth Korea
Study dates
16 Jan 2018to 12 Oct 2018
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 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

16 sites in 1 country.

16 sites in 1 country

South Korea16 sites

  • Kosin University Gospel Hospital

    Busan, Seo-gu, 602-702

  • Busan National University Hospital

    Busan

  • Inje University Busan Paik Hospital

    Busan

  • Hallym University Chuncheon Seonsim Hospital

    Chuncheon

  • Keimyung University Dongsan Medical Center

    Daegu, Gyeongsangbuk-do

  • Kyungpook National University Hospital

    Daegu, Gyeongsangbuk-do

  • Yeungnam University Medical Center

    Daegu

  • Chonnam National University Hospital

    Gwangju, Donggu, Jebongro, 501-757

  • Wonkwang University Hospital

    Iksan

  • Jeju National University Hospital

    Jeju City

  • Chonbuk National University Hospital

    Jeonju

  • Seoul National University Bundang Hospital

    Seongnam

  • Hanyang University Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Phase 2, 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 2, 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, CKD-495 150mg, Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg, Rebamipide 100mg, Placebo of the CKD-495 75mg
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.

  • CKD-495 150mgDrug

    CKD-495 150mg Tab.

  • Artemisiae argyi folium 95% ethanol ext.(20→1) 60mgDrug

    Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.

  • Rebamipide 100mgDrug

    Rebamipide 100mg Tab.

  • Placebo of the CKD-495 75mgDrug

    Placebo of the CKD-495 75mg Tab.

  • Placebo of the CKD-495 150mgDrug

    Placebo of the CKD-495 150mg Tab.

  • Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mgDrug

    Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.

  • Placebo of the Rebamipide 100mgDrug

    Placebo of the Rebamipide 100mg Tab

Study groups in NCT03437785
Study groupRoleWhat they receive
Experimental Group 1ExperimentalPatients assigned to this group are treated with CKD-495 75mg Tab.,and other 3 Placebo Tab.(Placebo of the CKD-495 150mg, ,Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab., Placebo of the Rebamipide 100mg Tab.)
Receives: Drug: CKD-495 75mg; Drug: Placebo of the CKD-495 150mg; Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Drug: Placebo of the Rebamipide 100mg
Experimental Group 2ExperimentalPatients assigned to this group are treated with CKD-495 150mg Tab.,and other 3 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab., Placebo of the Rebamipide 100mg Tab.)
Receives: Drug: CKD-495 150mg; Drug: Placebo of the CKD-495 75mg; Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Drug: Placebo of the Rebamipide 100mg
Placebo GroupPlacebo comparatorPatients assigned to this group are treated with 4 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of the CKD-495 150mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab., Placebo of the Rebamipide 100mg Tab.)
Receives: Drug: Placebo of the CKD-495 75mg; Drug: Placebo of the CKD-495 150mg; Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg; Drug: Placebo of the Rebamipide 100mg
Active comparator Group 1Active comparatorPatients assigned to this group are treated with Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab, and other 3 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of the CKD-495 150mg, Placebo of the Rebamipide 100mg Tab.)
Receives: Drug: Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg; Drug: Placebo of the CKD-495 75mg; Drug: Placebo of the CKD-495 150mg; Drug: Placebo of the Rebamipide 100mg
Active comparator Group 2Active comparatorPatients assigned to this group are treated with Rebamipide 100mg Tab.,and other 3 Placebo Tab.(Placebo of the CKD-495 75mg, Placebo of the CKD-495 150mg, Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.)
Receives: Drug: Rebamipide 100mg; Drug: Placebo of the CKD-495 75mg; Drug: Placebo of the CKD-495 150mg; Drug: Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement rate of gastric erosion

    50% decreased on erosive grade

    Measured: 14days after drug administrations

Secondary outcomes (5)

  1. cure rate of gastric erosion

    0 erosion

    Measured: 14days after drug administrations

  2. Improvement rate of symptoms

    50% decreased on the Subjective Symptoms total score

    Measured: 14days after drug administrations

  3. Improvement rate of gastric edema

    50% decreased on the Edema grade

    Measured: 14days after drug administrations

  4. Improvement rate of gastric erythema

    50% decreased on the Erythema grade

    Measured: 14days after drug administrations

  5. Improvement rate of gastric hemorrhage

    50% decreased 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.

  1. First posted19 Feb 2018
  2. Study start16 Jan 2018
  3. Primary completion12 Oct 2018
  4. Study completion12 Oct 2018

Resources

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
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03437785
Sponsor's protocol ID
174AG/CG17002
Status last verified
Feb 2018
First submitted
13 Feb 2018
Last updated
31 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park SH, Lee OY, Lee YC, Park KS, Park JJ, Park MI, Song GA, Lee DH, Jung H, Kim SK, Kim TN, Choi SC, Jee SR, Rew JS, Lee ST, Choi EK, Baik GH, Park SJ. A Phase 2, Multi-Center, Randomized, Double-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients With Acute and Chronic Gastritis. Can J Gastroenterol Hepatol. 2025 Apr 10;2025:2702089. doi: 10.1155/cjgh/2702089. eCollection 2025.

    PubMed 40255536

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CKD-495 75mg, CKD-495 150mg and Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg in people with Gastritis, run by Chong Kun Dang Pharmaceutical at 16 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 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

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 NCT03437785, 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 31 Oct 2018.

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