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
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 250 participants or records.
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