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, 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

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.

© 2021 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

Figures

FIGURE 1
FIGURE 1
Randomisation protocol and patient disposition
FIGURE 2
FIGURE 2
Proportion of heartburn‐free days, according to the full‐analysis set or subgroup analysis of patients, who experienced moderate or severe heartburn symptom during the screening period
FIGURE 3
FIGURE 3
Daily proportions of patients without heartburn during treatment period, who experienced moderate or severe heartburn symptom during the screening period (subgroup analysis)

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