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.
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| 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).
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| Authors | Yoon Jin Choi, Dong Ho Lee, Myung Gyu Choi, Sung Joon Lee, Sung Kook Kim, Geun Am Song, Poong Lyul Rhee, Hwoon Yong Jung, Dae Hwan Kang, Yong Chan Lee, Si Hyung Lee, Suck Chei Choi, Ki Nam Shim, Sang Yong Seol, Jeong Seop Moon, Yong Woon Shin, Hyun Soo Kim, Soo Teik Lee, Jin Woong Cho, Eun Kwang Choi, Oh Young Lee, Jin Seok Jang |
| Journal | Journal of Korean medical science (J Korean Med Sci) Vol. 32 Issue 11 Pg. 1807-1813 (Nov 2017) ISSN: 1598-6357 [Electronic] Korea (South) |
| PMID | 28960033 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial) |
| Copyright | © 2017 The Korean Academy of Medical Sciences. |
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