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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.

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제1저자 최윤진 · 교신저자 이동호

소속 (22)
  1. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
  2. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. dhljohn@yahoo.com.
  3. Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
  4. Department of Internal Medicine, Kangwon National University Hospital, Chuncheon, Korea.
  5. Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.
  6. Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea.
  7. Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  8. Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
  9. Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea.
  10. Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
  11. Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
  12. Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, Korea.
  13. Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
  14. Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.
  15. Department of Internal Medicine, Inje University Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea.
  16. Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea.
  17. Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
  18. Department of Internal Medicine, Chonbuk University Medical School, Jeonju, Korea.
  19. Department of Internal Medicine, Presbyterian Medical Center, Jeonju, Korea.
  20. Department of Internal Medicine, Jeju National University Hospital, Jeju, Korea.
  21. Department of Internal Medicine, Hanyang University College Medicine, Seoul, Korea.
  22. 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

Fig. 1
Fig. 1 Schematic illustration of the double-blind technique in the present study. Square and oval shapes indicate the active drugs of DA-5204 and DA-9601, respectively.
Fig. 2
Fig. 2 Flow diagram of study patients. GI = gastrointestinal. *One subject was excluded for protocol violation and poor compliance.

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
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