Dataset Information

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.

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.

SUBMITTER: Kim GH

PROVIDER: S-EPMC8593495 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Publications

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.

Kim Gwang Ha GH Lee Hang Lak HL Joo Moon Kyung MK Park Hong Jun HJ Jung Sung Woo SW Lee Ok-Jae OJ Kim Hyungkil H Chun Hoon Jai HJ Lee Soo Teik ST Kim Ji Won JW Jeon Han Ho HH Chung Il-Kwun IK Kim Hyun-Soo HS Lee Dong Ho DH Kim Kyoung-Oh KO Lim Yun Jeong YJ Park Seun-Ja SJ Cho Soo-Jeong SJ Kim Byung-Wook BW Ko Kwang Hyun KH Jeon Seong Woo SW Kim Jae Gyu JG Sung In-Kyung IK Kim Tae Nyeun TN Sung Jae Kyu JK Park Jong-Jae JJ

Gut and liver 20211101 6

<h4>Background/aims</h4>: The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta<sup>Ⓡ</sup> (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis.<h4>Methods</h4>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<sup>Ⓡ</sup> thrice ...[more]

PMID: 33827990

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Dataset Information

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.

Background/aims

Methods

Results

Conclusions

Publications

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.

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