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.
10.3346/jkms.2017.32.11.1807
- Author:
Yoon Jin CHOI
1
;
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
Author Information
1. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. dhljohn@yahoo.com
- Publication Type:Clinical Trial ; Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Artemisia;
Gastritis;
Double-blind Study;
Adverse Drug Event;
Endoscopy
- MeSH:
Artemisia;
Double-Blind Method;
Drug-Related Side Effects and Adverse Reactions;
Endoscopy;
Gastritis*;
Humans;
Seoul
- From:Journal of Korean Medical Science
2017;32(11):1807-1813
- CountryRepublic of Korea
- Language:English
-
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)
