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 Studyopen access
- Authors
- Choi, YJ[Choi, Yoon Jin]; Lee, DH[Lee, Dong Ho]; Choi, MG[Choi, Myung-Gyu]; Lee, SJ[Lee, Sung Joon]; Kim, SK[Kim, Sung Kook]; Song, GA[Song, Geun Am]; Rhee, PL[Rhee, Poong-Lyul]; Jung, HY[Jung, Hwoon-Yong]; Kang, DH[Kang, Dae-Hwan]; Lee, YC[Lee, Yong Chan]; Lee, SH[Lee, Si Hyung]; Choi, SC[Choi, Suck Chei]; Shim, KN[Shim, Ki-Nam]; Seol, SY[Seol, Sang-Yong]; Moon, JS[Moon, Jeong Seop]; Shin, YW[Shin, Yong Woon]; Kim, HS[Kim, Hyun-Soo]; Lee, ST[Lee, Soo Teik]; Cho, JW[Cho, Jin Woong]; Choi, EK[Choi, Eun Kwang]; Lee, OY[Lee, Oh Young]; Jang, JS[Jang, Jin Seok]
- Issue Date
- Nov-2017
- Publisher
- KOREAN ACAD MEDICAL SCIENCES
- Keywords
- Artemisia; Gastritis; Double-blind Study; Adverse Drug Event; Endoscopy
- Citation
- JOURNAL OF KOREAN MEDICAL SCIENCE, v.32, no.11, pp.1807 - +
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- JOURNAL OF KOREAN MEDICAL SCIENCE
- Volume
- 32
- Number
- 11
- Start Page
- 1807
- End Page
- +
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/26633
- DOI
- 10.3346/jkms.2017.32.11.1807
- ISSN
- 1011-8934
- 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 DA9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis.
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