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Cited 2 time in webofscience Cited 4 time in scopus
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Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, Double-Blind, Active Control, Noninferiority, Multicenter, Phase 3 Study

Authors
Kim, Gwang HaLee, Hang LakJoo, Moon KyungPark, Hong JunJung, Sung WooLee, Ok-JaeKim, HyungkilChun, Hoon JaiLee, Soo TeikKim, Ji WonJeon, Han HoChung, Il-KwunKim, Hyun-SooLee, Dong HoKim, Kyoung-OhLim, Yun JeongPark, Seun-JaCho, Soo-JeongKim, Byung-WookKo, Kwang HyunJeon, Seong WooKim, Jae GyuSung, In-KyungKim, Tae NyeunSung, Jae KyuPark, Jong-Jae
Issue Date
Nov-2021
Publisher
거트앤리버 발행위원회
Keywords
Adverse drug reaction; Gastritis; Intention-to-treat analysis; Phase III clinical trial; Rebamipide
Citation
Gut and Liver, v.15, no.6, pp.841 - 850
Indexed
SCIE
SCOPUS
KCI
Journal Title
Gut and Liver
Volume
15
Number
6
Start Page
841
End Page
850
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/54520
DOI
10.5009/gnl20338
ISSN
1976-2283
Abstract
Background/Aims: The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta (R) (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis. Methods: This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta (R) thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta (R), n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta (R), n=215). The posttreatment assessments included the primary (erosion im-provement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of red-ness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated. Results: According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta (R)-treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta (R)- treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was -4.01% (95% confidence interval [CI], -13.09% to 5.06%) in the ITT analysis and -4.44% (95% CI, -13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta (R)-treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates. Conclusions: The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta (R)) thrice daily. Both formulations showed a similar efficacy in treat-ing erosive gastritis. (Gut Liver, Published online April 7, 2021)
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Chun, Hoon Jai
Anam Hospital (Department of Gastroenterology and Hepatology, Anam Hospital)
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