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- Title
Randomised clinical trial: comparison of tegoprazan and placebo in non‐erosive reflux disease.
- Authors
Kim, Seung Han; Cho, Kwang Bum; Chun, Hoon Jai; Lee, Sang Woo; Kwon, Joong Goo; Lee, Dong Ho; Kim, Sang Gyun; Jung, Hwoon‐Yong; Kim, Ji Won; Lee, Joon Seong; Park, Hyojin; Choi, Suck Chei; Jee, Sam Ryong; Kim, Hyun‐Soo; Ko, Kwang Hyun; Park, Seun Ja; Lee, Yong Chan; Park, Soo Heon; Kim, Ah Rong; Kim, Eun Ji
- Abstract
Summary: Background: Tegoprazan is a novel, fast‐ and long‐acting potassium‐competitive acid blocker that suppresses gastric acid secretion, which could benefit patients with non‐erosive reflux disease (NERD), a type of gastroesophageal reflux disease. Aim: To evaluate the efficacy and safety profiles of tegoprazan compared with those of a placebo in Korean patients with NERD. Methods: In this phase 3, double‐blind, placebo‐controlled, multicentre study, 324 Korean patients with NERD were randomised into three treatment groups: tegoprazan 50 mg, tegoprazan 100 mg and placebo. These drugs were provided once daily for 4 weeks. The primary endpoint was the proportion of patients with complete resolution of major symptoms (both heartburn and regurgitation) for the last 7 days of the 4‐week treatment period. Other outcomes related to efficacy, safety and tolerability were also evaluated. Results: Among all, 42.5% (45/106), 48.5% (48/99) and 24.2% (24/99) of patients showed complete resolution of major symptoms at week 4 after receiving tegoprazan 50 mg, tegoprazan 100 mg, and placebo, respectively. Both doses of tegoprazan showed superior efficacy than the placebo (P = 0.0058 and P = 0.0004, respectively). The complete resolution rates of heartburn and proportions of heartburn‐free days (as other efficacy outcomes) were significantly higher in both tegoprazan groups than in the placebo group (P < 0.05 for all). No significant difference in the incidence of treatment‐emergent adverse events were noted. Conclusions: Tegoprazan 50 and 100 mg showed superior therapeutic efficacy compared with the placebo, as well as a favourable safety profile in patients with NERD. Registration number: ClinicalTrials.gov identifier NCT02556021.
- Subjects
TREATMENT effectiveness; KOREANS; PLACEBOS; CLINICAL trials; GASTRIC acid; H2 receptor antagonists; PARIETAL cells
- Publication
Alimentary Pharmacology & Therapeutics, 2021, Vol 54, Issue 4, p402
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/apt.16477