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Clinical Trial
. 2021 Nov 15;15(6):841-850.
doi: 10.5009/gnl20338.

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

Gwang Ha Kim  1 , Hang Lak Lee  2 , Moon Kyung Joo  3 , Hong Jun Park  4 , Sung Woo Jung  5 , Ok-Jae Lee  6 , Hyungkil Kim  7 , Hoon Jai Chun  8 , Soo Teik Lee  9 , Ji Won Kim  10 , Han Ho Jeon  11 , Il-Kwun Chung  12 , Hyun-Soo Kim  13 , Dong Ho Lee  14 , Kyoung-Oh Kim  15 , Yun Jeong Lim  16 , Seun-Ja Park  17 , Soo-Jeong Cho  18 , Byung-Wook Kim  19 , Kwang Hyun Ko  20 , Seong Woo Jeon  21 , Jae Gyu Kim  22 , In-Kyung Sung  23 , Tae Nyeun Kim  24 , Jae Kyu Sung  25 , Jong-Jae Park  3
Affiliations
Clinical Trial

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

Gwang Ha Kim et al. Gut Liver. .

Abstract

Background/aims: : The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of MucostaⓇ (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Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; MucostaⓇ, n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; MucostaⓇ, n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, 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Ⓡ-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Ⓡ-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Ⓡ-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Ⓡ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.

Keywords: Adverse drug reaction; Gastritis; Intention-to-treat analysis; Phase III clinical trial; Rebamipide.

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Conflict of interest statement

CONFLICTS OF INTEREST

G.H.K. and B.W.K. are editorial board members of the Journal but were not involved in the peer reviewer selection, evaluation, or decision process of this article. This study was supported by Addpharma Co., Ltd. (Youngin, Korea). No other potential conflicts of interest relevant to this article were reported.

Figures

Fig. 1
Fig. 1
Flowchart of the patients included in the study. ITT, intention-to-treat; PP, per-protocol.
See this image and copyright information in PMC

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