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NCT Number: NCT04255589

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

To Evaluate the Efficacy and Safety of CKD-495

Completed

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Key information

Conditions

Gastritis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Stomach Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chonnam National University Hospital, Gwangju, Donggu, South Korea

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CKD-495 75mg

Drug

CKD-495 75mg Tab.

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

Drug

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

Placebo of the CKD-495 75mg

Drug

Placebo of the CKD-495 75mg Tab.

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

Drug

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

Primary outcomes

  1. Improvement rate of gastric erosion

    Time frame: 14days after drug administrations

    50% change on erosive grade

Secondary outcomes

  1. cure rate of gastric erosion

    Time frame: 14days after drug administrations

    0 erosion

  2. Improvement rate of symptoms

    Time frame: 14days after drug administrations

    50% change on the Subjective Symptoms total score

  3. Improvement rate of gastric edema

    Time frame: 14days after drug administrations

    50% change on the Edema grade

  4. Improvement rate of gastric erythema

    Time frame: 14days after drug administrations

    50% change on the Erythema grade

  5. Improvement rate of gastric hemorrhage

    Time frame: 14days after drug administrations

    50% change on the Hemorrhage grade

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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