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; Hang Lak Lee; Moon Kyung Joo; Hong Jun Park; Sung Woo Jung; Ok Jae Lee; Hyungkil Kim; Hoon Jai Chun; Soo Teik Lee; Ji Won Kim; Han Ho Jeon; Il Kwun Chung; Hyun Soo Kim; Dong Ho Lee; Kyoung Oh Kim; Yun Jeong Lim; Seun Ja Park; Soo Jeong Cho; Byung Wook Kim; Kwang Hyun Ko; Seong Woo Jeon; Jae Gyu Kim; In Kyung Sung; Tae Nyeun Kim; Jae Kyu Sung; Jong Jae Park

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, Hang Lak Lee, Moon Kyung Joo, Hong Jun Park, Sung Woo Jung, Ok Jae Lee, Hyungkil Kim, Hoon Jai Chun, Soo Teik Lee, Ji Won Kim, Han Ho Jeon, Il Kwun Chung, Hyun Soo Kim, Dong Ho Lee, Kyoung Oh Kim, Yun Jeong Lim, Seun Ja Park, Soo Jeong Cho, Byung Wook Kim, Kwang Hyun KoSeong Woo Jeon, Jae Gyu Kim, In Kyung Sung, Tae Nyeun Kim, Jae Kyu Sung, Jong Jae Park

Research output: Contribution to journal › Article › peer-review

12 Scopus citations

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.

Original language	English
Pages (from-to)	841-850
Number of pages	10
Journal	Gut and Liver
Volume	15
Issue number	6
DOIs	https://doi.org/10.5009/gnl20338
State	Published - 2021

Keywords

Adverse drug reaction
Gastritis
Intention-to-treat analysis
Phase III clinical trial
Rebamipide

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10.5009/gnl20338

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Kim, G. H., Lee, H. L., Joo, M. K., Park, H. J., Jung, S. W., Lee, O. J., Kim, H., Chun, H. J., Lee, S. T., Kim, J. W., Jeon, H. H., Chung, I. K., Kim, H. S., Lee, D. H., Kim, K. O., Lim, Y. J., Park, S. J., Cho, S. J., Kim, B. W., ... Park, J. J. (2021). 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. Gut and Liver, 15(6), 841-850. https://doi.org/10.5009/gnl20338

@article{b503313a571a4f68a4a03da408aaf57e,

title = "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{\textregistered} (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{\textregistered} thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta{\textregistered}, n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta{\textregistered}, 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{\textregistered}-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{\textregistered}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{\textregistered}-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{\textregistered}) 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",

author = "Kim, {Gwang Ha} and Lee, {Hang Lak} and Joo, {Moon Kyung} and Park, {Hong Jun} and Jung, {Sung Woo} and Lee, {Ok Jae} and Hyungkil Kim and Chun, {Hoon Jai} and Lee, {Soo Teik} and Kim, {Ji Won} and Jeon, {Han Ho} and Chung, {Il Kwun} and Kim, {Hyun Soo} and Lee, {Dong Ho} and Kim, {Kyoung Oh} and Lim, {Yun Jeong} and Park, {Seun Ja} and Cho, {Soo Jeong} and Kim, {Byung Wook} and Ko, {Kwang Hyun} and Jeon, {Seong Woo} and Kim, {Jae Gyu} and Sung, {In Kyung} and Kim, {Tae Nyeun} and Sung, {Jae Kyu} and Park, {Jong Jae}",

note = "Publisher Copyright: Copyright {\textcopyright} Gut and Liver.",

year = "2021",

doi = "10.5009/gnl20338",

language = "English",

volume = "15",

pages = "841--850",

journal = "Gut and Liver",

issn = "1976-2283",

publisher = "Joe Bok Chung",

number = "6",

}

Kim, GH, Lee, HL, Joo, MK, Park, HJ, Jung, SW, Lee, OJ, Kim, H, Chun, HJ, Lee, ST, Kim, JW, Jeon, HH, Chung, IK, Kim, HS, Lee, DH, Kim, KO, Lim, YJ, Park, SJ, Cho, SJ, Kim, BW, Ko, KH, Jeon, SW, Kim, JG, Sung, IK, Kim, TN, Sung, JK & Park, JJ 2021, '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', Gut and Liver, vol. 15, no. 6, pp. 841-850. https://doi.org/10.5009/gnl20338

TY - JOUR

T1 - Efficacy and safety of rebamipide versus its new formulation, AD-203, in patients with erosive gastritis

T2 - A randomized, double-blind, active control, noninferiority, multicenter, phase 3 study

AU - Kim, Gwang Ha

AU - Lee, Hang Lak

AU - Joo, Moon Kyung

AU - Park, Hong Jun

AU - Jung, Sung Woo

AU - Lee, Ok Jae

AU - Kim, Hyungkil

AU - Chun, Hoon Jai

AU - Lee, Soo Teik

AU - Kim, Ji Won

AU - Jeon, Han Ho

AU - Chung, Il Kwun

AU - Kim, Hyun Soo

AU - Lee, Dong Ho

AU - Kim, Kyoung Oh

AU - Lim, Yun Jeong

AU - Park, Seun Ja

AU - Cho, Soo Jeong

AU - Kim, Byung Wook

AU - Ko, Kwang Hyun

AU - Jeon, Seong Woo

AU - Kim, Jae Gyu

AU - Sung, In Kyung

AU - Kim, Tae Nyeun

AU - Sung, Jae Kyu

AU - Park, Jong Jae

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - Adverse drug reaction

KW - Gastritis

KW - Intention-to-treat analysis

KW - Phase III clinical trial

KW - Rebamipide

UR - http://www.scopus.com/inward/record.url?scp=85119337237&partnerID=8YFLogxK

U2 - 10.5009/gnl20338

DO - 10.5009/gnl20338

M3 - Article

C2 - 33827990

AN - SCOPUS:85119337237

SN - 1976-2283

VL - 15

SP - 841

EP - 850

JO - Gut and Liver

JF - Gut and Liver

IS - 6

ER -

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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