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
Abstract
Background/Aims: (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis. Methods: , 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: -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates. Conclusions: ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.