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