Tegoprazan was found to offer
effective and sustained symptom relief to NERD patients.
In non-erosive reflux disease (NERD) people, oral administration of 50 and 100 mg of tegoprazan demonstrated a favorable safety profile and superior efficacy than placebo in a phase 3 randomized clinical trial. This multicentre, double-blind, placebo-controlled study was carried to investigate the safety and efficacy profiles of tegoprazan (a novel, fast- and long-acting potassium-competitive acid blocker) in comparison with placebo in 324 Korean people suffering from NERD.
Participants were randomly allocated into three therapy groups: 50 mg tegoprazan (n=108), 100 mg tegoprazan (n=108) and placebo (n=108) given once daily for four weeks. The percentage of people with complete resolution of major symptoms (both regurgitation and heartburn) for the last seven days of the four-week therapy period was the major outcome parameter. In addition, other outcomes associated with tolerability, efficacy, and safety were also assessed.
The proportion of people demonstrating complete resolution of major symptoms at week four after receiving placebo and tegoprazan is shown in Table 1:
Both the doses of tegoprazan
depicted superior efficacy compared to placebo. Compared to placebo-recipients,
both the tegoprazan arms displayed a substantially greater percentage of
heartburn-free days and complete resolution rates of heartburn. No profound
differences were witnessed in the occurrence of treatment-emergent side
effects. Thus, tegoprazan is an effective therapeutic agent for the management
of NERD.
Alimentary Pharmacology & Therapeutics
Randomised clinical trial: comparison of tegoprazan and placebo in non-erosive reflux disease
Seung Han Kim et al.
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