Gut Liver.
2024 Jan;18(1):70-76. 10.5009/gnl220446.
Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study
- Kim JH
1 - Jung HY2
- Yoo IK3
- Park SY4
- Kim JG5
- Sung JK6
- Jang JS7
- Cheon GJ8
- Kim KO9
- Kim TO10
- Lee ST11
- Cho KB12
- Chun HJ13
- Park JJ14
- Park MI15
- Jang JY16
- Jeon SW17
- Cho JW18
- Kang DH19
- Kim GH20
- Kim JJ21
- Kim SG22
- Kim N23
- Lee YC24
- Hong SJ25
- Kim HS26
- Lee S27
- Lee SW28
- Affiliations
-
- 1Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
- 2Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
- 3Division of Gastroenterology, Department of Internal Medicine, Cha Bundang Medical Center, Seongnam, Korea
- 4Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
- 5Division of Gastroenterology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
- 6Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea
- 7Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea
- 8Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea
- 9Department of Gastroenterology, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea
- 10Department of Internal Medicine, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea
- 11Division of Gastroenterology, Department of Internal Medicine, Jeonbuk National University Hospital, Jeonbuk National University Medical School, Jeonju, Korea
- 12Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea
- 13Department of Gastroenterology, Korea University Anam Hospita, Seoul, Korea
- 14Department of Gastroenterology, Korea University Guro Hospital, Seoul, Korea
- 15Division of Gastroenterology, Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea
- 16Division of Gastroenterology and Hepatology, Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul, Korea
- 17Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea
- 18Department of Internal Medicine, Presbyterian Medical Center, Jeonju, Korea
- 19Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea
- 20Department of Internal Medicine, Pusan National University College of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea
- 21Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
- 22Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
- 23Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
- 24Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
- 25Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea
- 26Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Korea
- 27Clinical R & D Department, Daewon Pharmaceutical, Seoul, Korea
- 28Department of Gastroenterology, Korea University Ansan Hospital, Ansan, Korea
- KMID: 2551036
- DOI: http://doi.org/10.5009/gnl220446
Abstract
- Background/Aims
H2 receptor antagonists (H2RA) have been used to treat gastritis by inhibiting gastric acid. Proton pump inhibitors (PPIs) are more potent acid suppressants than H2RA. However, the efficacy and safety of low-dose PPI for treating gastritis remain unclear. The aim was to investigate the efficacy and safety of low-dose PPI for treating gastritis.
Methods
A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set included 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared.
Results
According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different.
Conclusions
DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, lowdose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).
- Full Text Links
-
- Actions
-
Cited
- CITED
-
- Close
- Share
-
- Similar articles
-
- Efficacy and Safety of Naftopidil in Patients With Neurogenic Lower Urinary Tract Dysfunction: An 8-Week, Active-Controlled, Stratified-Randomized, Double-Blind, Double-Dummy, Parallel Group, Noninferiority, Multicenter Design
- Comparison of efficacy of multimatrix mesalazine 4.8 g/day once-daily with other high-dose mesalazine in active ulcerative colitis: a randomized, double-blind study
- A Phase III Clinical Trial of Stillen(TM) for Erosive Gastritis
- Efficacy and safety of mirikizumab as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a subgroup analysis of the global phase 3 LUCENT-1 and LUCENT-2 studies
- A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease
