J Korean Med Sci. 2017;32(11):1807-1813.
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.
제1저자 최윤진 · 교신저자 이동호
소속 (22)
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
- Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. dhljohn@yahoo.com.
- Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
- Department of Internal Medicine, Kangwon National University Hospital, Chuncheon, Korea.
- Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.
- Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea.
- Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
- Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
- Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea.
- Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
- Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
- Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, Korea.
- Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
- Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.
- Department of Internal Medicine, Inje University Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea.
- Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea.
- Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
- Department of Internal Medicine, Chonbuk University Medical School, Jeonju, Korea.
- Department of Internal Medicine, Presbyterian Medical Center, Jeonju, Korea.
- Department of Internal Medicine, Jeju National University Hospital, Jeju, Korea.
- Department of Internal Medicine, Hanyang University College Medicine, Seoul, Korea.
- Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
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).
© 2017 The Korean Academy of Medical Sciences.
Keywords
Adverse Drug EventArtemisiaDouble-blind StudyEndoscopyGastritis
Figures
그림 출처: PubMed Central 공개 논문 (PMC5639061)
Conflict of interest statement
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.
그 밖의 정보
- 출판 형태
- Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial
- 저널
- Journal of Korean medical science · eISSN 1598-6357
- MeSH
- Adult · Double-Blind Method · Drug Administration Schedule · Female · Gastric Mucosa / pathology · Gastritis / drug therapy · Gastrointestinal Diseases / etiology · Gastroscopy · Humans · Male · Middle Aged · Plant Extracts / adverse effects / therapeutic use · Treatment Outcome
- Substances
- DA 9601 · Plant Extracts
- 데이터
- ClinicalTrials.gov: NCT02282670
- 참고문헌
- 15편