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

CKD-495 is a newly developed drug extracted from Cinnamomum cassia Presl. This phase II study assessed the clinical benefits of CKD-495 in the treatment of acute and chronic gastritis. This study randomly assigned 250 patients with endoscopically-proven gastric mucosal erosion to five groups. The groups received either 75 mg or 150 mg of CKD-495, 100 mg of rebamipide, 60 mg of Artemisiae argyi folium 95% ethanol ext. (20 ⟶ 1) (Stillen; Dong-A ST Co., Ltd., Seoul, Korea), or placebo for 2 weeks, respectively. The primary endpoint was the erosion improvement rate, and the secondary endpoints were erosion cure rates, improvement rates of gastrointestinal symptoms, edema, redness, and hemorrhage. Drug-related adverse events were evaluated. The endoscopic erosion improvement rate was significantly higher in the 75 mg CKD-495 group than in the other groups in both the full analysis set (73% vs. 41%, 45%, 52%, 48% for the 75 mg CKD-495, 150 mg CKD-495, placebo, 60 mg Stillen, and 100 mg rebamipide groups, respectively) and the per-protocol set (PPS) (75% vs. 37%, 45%, 51%, 50%). The cure rate of gastric erosion was significantly higher in the 75 mg CKD-495 group than in the other groups. The improvement rates of hemorrhage erosion were significantly higher in the 150-mg CKD-495 group. No significant differences were observed in the safety profiles. No serious adverse events or drug reactions were observed. These results demonstrate that 75 mg of CKD-495 has excellent efficacy for the treatment of endoscopic and symptomatic improvements for acute and chronic gastritis. <b>Trial Registration:</b> ClinicalTrials.gov identifier: NCT03437785.

Authors

Institutions

Publication Details

Journal
Canadian Journal of Gastroenterology and Hepatology
Published
2025-01-01
DOI
https://doi.org/10.1155/cjgh/2702089
Citations
2
Primary Topic
Helicobacter pylori-related gastroenterology studies
Type
article
Field-Weighted Citation Impact
4.01
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

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

Jong Sun Rew, Ha‐Kyun Jung, Gwang Ho Baik, Jong‐Jae Park et al.
2 citations
Canadian Journal of Gastroenterology and Hepatology
Helicobacter pylori-related gastroenterology studies
4.01
article

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

Jong Sun Rew, Ha‐Kyun Jung, Gwang Ho Baik, Jong‐Jae Park, Kyung Sik Park, Soo Teik Lee, Tae Nyeun Kim, Shin Jung Park, Eun Kwang Choi, Moo In Park, Sam Ryong Jee, Sung Kook Kim, Geun Am Song, Oh Young Lee, Yong Chan Lee, Dong Ho Lee, Su Hyun Park, Suck‐Chei Choi
article en
2 citations

Abstract

CKD-495 is a newly developed drug extracted from Cinnamomum cassia Presl. This phase II study assessed the clinical benefits of CKD-495 in the treatment of acute and chronic gastritis. This study randomly assigned 250 patients with endoscopically-proven gastric mucosal erosion to five groups. The groups received either 75 mg or 150 mg of CKD-495, 100 mg of rebamipide, 60 mg of Artemisiae argyi folium 95% ethanol ext. (20 ⟶ 1) (Stillen; Dong-A ST Co., Ltd., Seoul, Korea), or placebo for 2 weeks, respectively. The primary endpoint was the erosion improvement rate, and the secondary endpoints were erosion cure rates, improvement rates of gastrointestinal symptoms, edema, redness, and hemorrhage. Drug-related adverse events were evaluated. The endoscopic erosion improvement rate was significantly higher in the 75 mg CKD-495 group than in the other groups in both the full analysis set (73% vs. 41%, 45%, 52%, 48% for the 75 mg CKD-495, 150 mg CKD-495, placebo, 60 mg Stillen, and 100 mg rebamipide groups, respectively) and the per-protocol set (PPS) (75% vs. 37%, 45%, 51%, 50%). The cure rate of gastric erosion was significantly higher in the 75 mg CKD-495 group than in the other groups. The improvement rates of hemorrhage erosion were significantly higher in the 150-mg CKD-495 group. No significant differences were observed in the safety profiles. No serious adverse events or drug reactions were observed. These results demonstrate that 75 mg of CKD-495 has excellent efficacy for the treatment of endoscopic and symptomatic improvements for acute and chronic gastritis. <b>Trial Registration:</b> ClinicalTrials.gov identifier: NCT03437785.

Canadian Journal of Gastroenterology and HepatologyVol. 2025(1)
Hallym University (KR), Yonsei University (KR), Severance Hospital (KR), Korea University Medical Center (KR), Seoul National University Hospital (KR), Seoul National University Bundang Hospital (KR), Kyungpook National University (KR), Chong Kun Dang Bio (South Korea) (KR), Chonnam National University Hospital (KR), WonKwang Health Science University (KR), Inje University Busan Paik Hospital (KR), Jeonbuk National University Hospital (KR), Wonkwang Digital University (KR), Hallym University Chuncheon Sacred Heart Hospital (KR), Yeungnam University College, Hanyang University (KR), Pusan National University (KR), Keimyung University (KR), Yeungnam University (KR), Wonkwang University (KR), Jeju National University (KR), Kosin University (KR)
Openalex Percentile: Top 8%
Helicobacter pylori-related gastroenterology studies
4.01
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.