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

• DOI: 10.3346/jkms.2017.32.11.1807
• Publication Date: 2017-09-29T12:57:58Z
• 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
• Keywords: Double blind study

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