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Randomised clinical trial: comparison of tegoprazan and placebo in non-erosive reflux disease

 Seung Han Kim  ;  Kwang Bum Cho  ;  Hoon Jai Chun  ;  Sang Woo Lee  ;  Joong Goo Kwon  ;  Dong Ho Lee  ;  Sang Gyun Kim  ;  Hwoon-Yong Jung  ;  Ji Won Kim  ;  Joon Seong Lee  ;  Hyojin Park  ;  Suck Chei Choi  ;  Sam Ryong Jee  ;  Hyun-Soo Kim  ;  Kwang Hyun Ko  ;  Seun Ja Park  ;  Yong Chan Lee  ;  Soo Heon Park  ;  Ah Rong Kim  ;  Eun Ji Kim  ;  Hyun Wook Park  ;  Bong Tae Kim  ;  Geun Seog Song 
 ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Vol.54(4) : 402-411, 2021-07 
Journal Title
Issue Date
Benzene Derivatives ; Double-Blind Method ; Gastroesophageal Reflux* / drug therapy ; Heartburn / drug therapy ; Humans ; Imidazoles* ; Treatment Outcome
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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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Hyo Jin(박효진) ORCID logo https://orcid.org/0000-0003-4814-8330
Lee, Yong Chan(이용찬) ORCID logo https://orcid.org/0000-0001-8800-6906
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