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CompletedNCT03437785Updated Oct 31, 2018

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

A Phase 2 interventional study of CKD-495 75mg and CKD-495 150mg in Gastritis, sponsored by Chong Kun Dang Pharmaceutical. Completed at 16 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-10-31.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 32 studies in Gastritis with a site in Korea, Republic of — 3 open to participants now, 3 under way, none of them phase 3. Gastritis · Korea, Republic of.

Enrollment
12th of 25
250 · median 242
Started
2018
the only one that year
Phase 2
4 of 32
none open now
Registered
15th of 32
by date
Lead sponsor
3 of 32
Chong Kun Dang Pharmaceutical

Among the 32 studies in Gastritis with a site in Korea, Republic of, this one is the 12th largest by enrollment of the 25 interventional ones that give a count, is the only one that started in 2018, is one of 4 in phase 2, and was the 15th registered.

Gastritis

135 studies on the registry are indexed under Gastritis; 23 are open to participants now.

Browse Gastritis studies →

Open to participants now

3 of the 32 studies in Gastritis with a site in Korea, Republic of are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 11 Gastritis studies recruiting now, 6 (55%) set no upper age limit and 5 (45%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

03

Conditions studied

  • Gastritis

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Keywords

  • Acute Gastritis
  • Chronic Gastritis
  • Cinnamic acid
  • CKD-495
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or Female subjects aged ≥ 19
  2. 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
  3. Patients who have more than 1 subjective symptom

Exclusion criteria

Exclusion Criteria:

  1. Patients with peptic ulcer, gastroesophageal reflux disease, malignant tumor in the digestive system or coagulation disorder, or taking antithrombotic medicine
  2. 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
  3. Patients who have to take medicine that could cause gastritis
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    Experimental Group 1

    Patients 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.)

    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
    Experimental Group 2

    Patients 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.)

    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 comparator
    Placebo Group

    Patients 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.)

    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
    Active comparator Group 1

    Patients 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.)

    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
    Active comparator Group 2

    Patients 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.)

    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

Interventions

  • DrugCKD-495 75mg

    CKD-495 75mg Tab.

  • DrugCKD-495 150mg

    CKD-495 150mg Tab.

  • DrugArtemisiae argyi folium 95% ethanol ext.(20→1) 60mg

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

  • Rebamipide 100mg Tab.

  • DrugPlacebo of the CKD-495 75mg

    Placebo of the CKD-495 75mg Tab.

  • DrugPlacebo of the CKD-495 150mg

    Placebo of the CKD-495 150mg Tab.

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

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

  • DrugPlacebo of the Rebamipide 100mg

    Placebo of the Rebamipide 100mg Tab

06

What researchers measure

Primary outcomes

  1. Improvement rate of gastric erosion

    50% decreased on erosive grade

    Time frame: 14days after drug administrations

Secondary outcomes

  1. cure rate of gastric erosion

    0 erosion

    Time frame: 14days after drug administrations

  2. Improvement rate of symptoms

    50% decreased on the Subjective Symptoms total score

    Time frame: 14days after drug administrations

  3. Improvement rate of gastric edema

    50% decreased on the Edema grade

    Time frame: 14days after drug administrations

  4. Improvement rate of gastric erythema

    50% decreased on the Erythema grade

    Time frame: 14days after drug administrations

  5. Improvement rate of gastric hemorrhage

    50% decreased on the Hemorrhage grade

    Time frame: 14days after drug administrations

07

Study locations

16 sites
  • Chonnam National University Hospital
    Gwangju, Donggu, Jebongro 501-757, Korea, Republic of
  • Keimyung University Dongsan Medical Center
    Daegu, Gyeongsangbuk-do, Korea, Republic of
  • Kyungpook National University Hospital
    Daegu, Gyeongsangbuk-do, Korea, Republic of
  • Kosin University Gospel Hospital
    Busan, Seo-gu 602-702, Korea, Republic of
  • Busan National University Hospital
    Busan, Korea, Republic of
  • Inje University Busan Paik Hospital
    Busan, Korea, Republic of
  • Hallym University Chuncheon Seonsim Hospital
    Chuncheon, Korea, Republic of
  • Yeungnam University Medical Center
    Daegu, Korea, Republic of
  • Wonkwang University Hospital
    Iksan, Korea, Republic of
  • Jeju National University Hospital
    Jeju, Korea, Republic of
  • Chonbuk National University Hospital
    Jeonju, Korea, Republic of
  • Seoul National University Bundang Hospital
    Seongnam, Korea, Republic of
  • Hanyang University Hospital
    Seoul, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, Korea, Republic of
  • Seoul National University Hospital
    Seoul, Korea, Republic of
  • Severance Hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Oct 2018, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2018
First posted
Feb 19, 2018
StartActual
Jan 16, 2018
Primary completionActual
Oct 12, 2018
CompletionActual
Oct 12, 2018
Last update
Oct 31, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03437785
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Jan 16, 2018
Primary completion
Oct 12, 2018
Completion
Oct 12, 2018
Last update
Oct 31, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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