PMID- 28960033
OWN - NLM
STAT- MEDLINE
DCOM- 20180129
LR  - 20181113
IS  - 1598-6357 (Electronic)
IS  - 1011-8934 (Print)
IS  - 1011-8934 (Linking)
VI  - 32
IP  - 11
DP  - 2017 Nov
TI  - 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.
PG  - 1807-1813
LID - 10.3346/jkms.2017.32.11.1807 [doi]
AB  - 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).
CI  - (c) 2017 The Korean Academy of Medical Sciences.
FAU - Choi, Yoon Jin
AU  - Choi YJ
AUID- ORCID: 0000-0002-1922-9388
AD  - Department of Internal Medicine, Seoul National University Bundang Hospital, 
      Seongnam, Korea.
FAU - Lee, Dong Ho
AU  - Lee DH
AUID- ORCID: 0000-0002-6376-410X
AD  - Department of Internal Medicine, Seoul National University Bundang Hospital, 
      Seongnam, Korea. dhljohn@yahoo.com.
FAU - Choi, Myung Gyu
AU  - Choi MG
AUID- ORCID: 0000-0003-4083-5187
AD  - Department of Internal Medicine, The Catholic University of Korea College of 
      Medicine, Seoul, Korea.
FAU - Lee, Sung Joon
AU  - Lee SJ
AUID- ORCID: 0000-0002-6451-0400
AD  - Department of Internal Medicine, Kangwon National University Hospital, Chuncheon, 
      Korea.
FAU - Kim, Sung Kook
AU  - Kim SK
AUID- ORCID: 0000-0002-2861-8123
AD  - Department of Internal Medicine, Kyungpook National University School of 
      Medicine, Daegu, Korea.
FAU - Song, Geun Am
AU  - Song GA
AUID- ORCID: 0000-0003-2100-8522
AD  - Department of Internal Medicine, Pusan National University School of Medicine, 
      Busan, Korea.
FAU - Rhee, Poong Lyul
AU  - Rhee PL
AUID- ORCID: 0000-0003-0495-5296
AD  - Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University 
      School of Medicine, Seoul, Korea.
FAU - Jung, Hwoon Yong
AU  - Jung HY
AUID- ORCID: 0000-0003-1281-5859
AD  - Department of Internal Medicine, University of Ulsan College of Medicine, Asan 
      Medical Center, Seoul, Korea.
FAU - Kang, Dae Hwan
AU  - Kang DH
AD  - Department of Internal Medicine, Pusan National University Yangsan Hospital, 
      Yangsan, Korea.
FAU - Lee, Yong Chan
AU  - Lee YC
AUID- ORCID: 0000-0001-8800-6906
AD  - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 
      Korea.
FAU - Lee, Si Hyung
AU  - Lee SH
AUID- ORCID: 0000-0001-7221-7506
AD  - Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, 
      Korea.
FAU - Choi, Suck Chei
AU  - Choi SC
AUID- ORCID: 0000-0003-1338-3306
AD  - Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, 
      Korea.
FAU - Shim, Ki Nam
AU  - Shim KN
AUID- ORCID: 0000-0003-4004-6292
AD  - Department of Internal Medicine, Ewha Womans University School of Medicine, 
      Seoul, Korea.
FAU - Seol, Sang Yong
AU  - Seol SY
AD  - Department of Internal Medicine, Inje University Busan Paik Hospital, Inje 
      University College of Medicine, Busan, Korea.
FAU - Moon, Jeong Seop
AU  - Moon JS
AUID- ORCID: 0000-0002-5909-8159
AD  - Department of Internal Medicine, Inje University Seoul Paik Hospital, Inje 
      University College of Medicine, Seoul, Korea.
FAU - Shin, Yong Woon
AU  - Shin YW
AUID- ORCID: 0000-0001-7876-6178
AD  - Department of Internal Medicine, Inha University College of Medicine, Incheon, 
      Korea.
FAU - Kim, Hyun Soo
AU  - Kim HS
AUID- ORCID: 0000-0003-4834-0496
AD  - Department of Internal Medicine, Chonnam National University Medical School, 
      Gwangju, Korea.
FAU - Lee, Soo Teik
AU  - Lee ST
AUID- ORCID: 0000-0002-2975-053X
AD  - Department of Internal Medicine, Chonbuk University Medical School, Jeonju, 
      Korea.
FAU - Cho, Jin Woong
AU  - Cho JW
AUID- ORCID: 0000-0002-0296-8045
AD  - Department of Internal Medicine, Presbyterian Medical Center, Jeonju, Korea.
FAU - Choi, Eun Kwang
AU  - Choi EK
AUID- ORCID: 0000-0002-6376-1849
AD  - Department of Internal Medicine, Jeju National University Hospital, Jeju, Korea.
FAU - Lee, Oh Young
AU  - Lee OY
AUID- ORCID: 0000-0002-6025-530X
AD  - Department of Internal Medicine, Hanyang University College Medicine, Seoul, 
      Korea.
FAU - Jang, Jin Seok
AU  - Jang JS
AD  - Department of Internal Medicine, Dong-A University College of Medicine, Busan, 
      Korea.
LA  - eng
SI  - ClinicalTrials.gov/NCT02282670
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Korea (South)
TA  - J Korean Med Sci
JT  - Journal of Korean medical science
JID - 8703518
RN  - 0 (DA 9601)
RN  - 0 (Plant Extracts)
SB  - IM
MH  - Adult
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Gastric Mucosa/pathology
MH  - Gastritis/*drug therapy
MH  - Gastrointestinal Diseases/etiology
MH  - Gastroscopy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Plant Extracts/adverse effects/*therapeutic use
MH  - Treatment Outcome
PMC - PMC5639061
OTO - NOTNLM
OT  - Adverse Drug Event
OT  - Artemisia
OT  - Double-blind Study
OT  - Endoscopy
OT  - Gastritis
COIS- Min-hee Oh is a biostatistician of Dong-A ST Co., but she made no influence on 
      this work in relation with the company or its products. Other authors declare 
      that they have no potential conflicts of interest.
EDAT- 2017/09/30 06:00
MHDA- 2018/01/30 06:00
PMCR- 2017/11/01
CRDT- 2017/09/30 06:00
PHST- 2017/02/14 00:00 [received]
PHST- 2017/08/14 00:00 [accepted]
PHST- 2017/09/30 06:00 [entrez]
PHST- 2017/09/30 06:00 [pubmed]
PHST- 2018/01/30 06:00 [medline]
PHST- 2017/11/01 00:00 [pmc-release]
AID - 32.1807 [pii]
AID - 10.3346/jkms.2017.32.11.1807 [doi]
PST - ppublish
SO  - J Korean Med Sci. 2017 Nov;32(11):1807-1813. doi: 10.3346/jkms.2017.32.11.1807.