J Korean Med Sci.  2017 Nov;32(11):1807-1813. 10.3346/jkms.2017.32.11.1807.

Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study

• Choi YJ
• Lee DH
• Choi MG
• Lee SJ
• Kim SK
• Song GA
• Rhee PL
• Jung HY
• Kang DH
• Lee YC
• Lee SH
• Choi SC
• Shim KN
• Seol SY
• Moon JS
• Shin YW
• Kim HS
• Lee ST
• Cho JW
• Choi EK
• Lee OY
• Jang JS

• KMID: 2390307
• DOI: http://doi.org/10.3346/jkms.2017.32.11.1807

Abstract

This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was −0.4% (95% confidence interval, −9.8% to 9.1%), which was above the non-inferiority margin of −14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670)

Keyword

Artemisia; Gastritis; Double-blind Study; Adverse Drug Event; Endoscopy

MeSH Terms

Artemisia
Double-Blind Method
Drug-Related Side Effects and Adverse Reactions
Endoscopy
Gastritis*
Humans
Seoul

Figure

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  Fig. 1 Schematic illustration of the double-blind technique in the present study. Square and oval shapes indicate the active drugs of DA-5204 and DA-9601, respectively.

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  Fig. 2 Flow diagram of study patients. GI = gastrointestinal. *One subject was excluded for protocol violation and poor compliance.

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