Randomised clinical trial: tegoprazan, a novel potassium-competitive acid blocker, or lansoprazole in the treatment of gastric ulcer
- Cho, Yu Kyung; Choi, Myung-Gyu; Choi, Suck Chei; Lee, Kee Myung; Kim, Tae Oh; Park, Soo-Heon; Moon, Jeong Seop; Lim, Yun Jeong; Kang, Dae Hwan; Cheon, Gab Jin; Baik, Gwang Ho; Kim, Kyoung Oh; Cho, Kwang Bum; Jang, Jin Seok; Park, Jong-Jae; Son, Byoung Kwan; Jung, Hye-Kyung; Kim, Byung-Wook; Kim, Sung Kuk; Lee, Soo Teik; Cha, Jae Myung; Kim, Ah Rong; Kim, Eun Ji; Park, Hyun Wook; Song, Geun Seog
- Issue Date
- Blackwell Publishing Inc.
- Alimentary Pharmacology and Therapeutics, v.52, no.5, pp.789 - 797
- Journal Title
- Alimentary Pharmacology and Therapeutics
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- End Page
Tegoprazan is a novel potassium-competitive acid blocker for the treatment of acid-related disorders.
To assess whether tegoprazan is non-inferior to lansoprazole in terms of efficacy and safety in patients with gastric ulcers.
In this phase 3, double-blind, active control, multicentre study, 306 gastric ulcer patients were randomised to one of three treatment groups: tegoprazan 50 mg, tegoprazan 100 mg and lansoprazole 30 mg once daily for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed ulcers confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms and safety were assessed.
In the full analysis set, the cumulative healing rates at week 8 were 94.8% (91/96) for the tegoprazan 50 mg, 95.0% (94/99) for the tegoprazan 100 mg and 95.7% (89/93) for the lansoprazole 30 mg groups. At week 4, the respective healing rates were 90.6% (87/96), 91.9% (91/99), and 89.2% (83/93). In per protocol analysis, 4-week healing rates were 95.4% (84/88), 94.6% (88/93) and 92.9% (79/85) for tegoprazan 50 mg, tegoprazan 100 mg and lansoprazole 30 mg, respectively. Both doses of tegoprazan were non-inferior to lansoprazole in ulcer healing at 4 and 8 weeks. The incidence of drug-related treatment-emergent adverse events did not differ among groups. The increase in serum gastrin concentration was not higher in tegoprazan-treated patients than in lansoprazole-treated patients.
Tegoprazan 50 or 100 mg were not inferior to lansoprazole 30 mg once daily in the treatment of gastric ulcers.
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