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

• Published in: Journal of Korean medical science 2017-11, Vol.32 (11), p.1807-1813
• Main Authors: Choi, Yoon Jin, Lee, Dong Ho, Choi, Myung Gyu, Lee, Sung Joon, Kim, Sung Kook, Song, Geun Am, Rhee, Poong Lyul, Jung, Hwoon Yong, Kang, Dae Hwan, Lee, Yong Chan, Lee, Si Hyung, Choi, Suck Chei, Shim, Ki Nam, Seol, Sang Yong, Moon, Jeong Seop, Shin, Yong Woon, Kim, Hyun Soo, Lee, Soo Teik, Cho, Jin Woong, Choi, Eun Kwang, Lee, Oh Young, Jang, Jin Seok
• Format: Article
• Language: English
• Subjects: Adult; Double-Blind Method; Drug Administration Schedule; Female; Gastric Mucosa - pathology; Gastritis - drug therapy; Gastrointestinal Diseases - etiology; Gastroscopy; Humans; Male; Middle Aged; Original; Plant Extracts - adverse effects; Plant Extracts - therapeutic use; Treatment Outcome
• ISSN: 1011-8934; 1598-6357
• DOI: 10.3346/jkms.2017.32.11.1807

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).