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Cited 8 time in webofscience Cited 7 time in scopus
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Randomised clinical trial: comparison of tegoprazan and placebo in non-erosive reflux disease

Authors
Kim, Seung HanCho, Kwang BumChun, Hoon JaiLee, Sang WooKwon, Joong GooLee, Dong HoKim, Sang GyunJung, Hwoon-YongKim, Ji WonLee, Joon SeongPark, HyojinChoi, Suck CheiJee, Sam RyongKim, Hyun-SooKo, Kwang HyunPark, Seun JaLee, Yong ChanPark, Soo HeonKim, Ah RongKim, Eun JiPark, Hyun WookKim, Bong TaeSong, Geun Seog
Issue Date
Aug-2021
Publisher
WILEY
Citation
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, v.54, no.4, pp.402 - 411
Indexed
SCIE
SCOPUS
Journal Title
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
Volume
54
Number
4
Start Page
402
End Page
411
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/53869
DOI
10.1111/apt.16477
ISSN
0269-2813
Abstract
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.
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Lee, Sang Woo
안산병원 (Department of Gastroenterology and Hepatology, Ansan Hospital)
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