Randomised clinical trial: tegoprazan, a novel potassium‐competitive acid blocker, or lansoprazole in the treatment of gastric ulcer

• DOI: 10.1111/apt.15865
• Publication Date: 2020-07-23T15:10:55Z
• Authors: Yu Kyung Cho; Myung‐Gyu Choi; Suck Chei Choi; Kee Myung Lee; Tae Oh Kim; Soo‐Heon Park; Jeong Seop Moon; Yun Jeong Lim; Dae Hwan Kang; Gab Jin Cheon; Gwang Ho Baik; Kyoung Oh Kim; Kwang Bum Cho; Jin Seok Jang; Jong‐Jae Park; Byoung Kwan Son; Hye‐Kyung Jung; Byung‐Wook Kim; Sung Kuk Kim; Soo Teik Lee; Jae Myung Cha; Ah Rong Kim; Eun Ji Kim; Hyun Wook Park; Geun Seog Song
• Keywords: Lansoprazole; Clinical endpoint

Summary Background Tegoprazan is a novel potassium‐competitive acid blocker for the treatment of acid‐related disorders. Aims To assess whether tegoprazan non‐inferior to lansoprazole in terms efficacy and safety patients with gastric ulcers. Methods In this phase 3, double‐blind, active control, multicentre study, 306 ulcer were randomised one three groups: 50 mg, 100 mg 30 once daily 4 or 8 weeks. The primary endpoint was cumulative proportion healed ulcers confirmed by endoscopy up weeks from initiation. Symptoms assessed. Results full analysis set, healing rates at week 94.8% (91/96) 95.0% (94/99) 95.7% (89/93) groups. At 4, respective 90.6% (87/96), 91.9% (91/99), 89.2% (83/93). per protocol analysis, 4‐week 95.4% (84/88), 94.6% (88/93) 92.9% (79/85) respectively. Both doses incidence drug‐related treatment‐emergent adverse events did not differ among increase serum gastrin concentration higher tegoprazan‐treated than lansoprazole‐treated patients. Conclusions inferior