Dataset Information

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

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.

SUBMITTER: Kim SH

PROVIDER: S-EPMC8361733 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Kim Seung Han SH Cho Kwang Bum KB Chun Hoon Jai HJ Lee Sang Woo SW Kwon Joong Goo JG Lee Dong Ho DH Kim Sang Gyun SG Jung Hwoon-Yong HY Kim Ji Won JW Lee Joon Seong JS Park Hyojin H Choi Suck Chei SC Jee Sam Ryong SR Kim Hyun-Soo HS Ko Kwang Hyun KH Park Seun Ja SJ Lee Yong Chan YC Park Soo Heon SH Kim Ah Rong AR Kim Eun Ji EJ Park Hyun Wook HW Kim Bong Tae BT Song Geun Seog GS

Alimentary pharmacology & therapeutics 20210706 4

<h4>Background</h4>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.<h4>Aim</h4>To evaluate the efficacy and safety profiles of tegoprazan compared with those of a placebo in Korean patients with NERD.<h4>Methods</h4>In this phase 3, double-blind, placebo-controlled, multicentre study, 324 Korean patients with NERD w ...[more]

PMID: 34227708

Similar Datasets

Project description:BackgroundNon-erosive reflux disease (NERD), the most frequent phenotype of gastroesophageal reflux disease, presents without visible esophageal mucosal damage but significantly impacts patients' quality of life. Current treatments like proton pump inhibitors show limited efficacy for many NERD patients, necessitating alternative approaches. Jianpi Qinghua (JQ) granules, a traditional Chinese medicine, have shown promise in treating NERD by targeting symptoms of spleen deficiency and damp-heat syndrome.PurposeThis study aims to evaluate the efficacy and safety of JQ granules in treating patients with NERD characterized by spleen deficiency and damp-heat syndrome.Study designA multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted with a total of 78 NERD patients randomly assigned to receive either JQ granules or placebo for 4 weeks, followed by a 4-week follow-up period.MethodsSeventy-eight NERD patients with spleen deficiency and damp-heat syndrome were recruited and randomly assigned to receive either JQ granules (n = 39) or placebo (n = 39). The trial included a 1-week lead-in, followed by a 4-week double-blind treatment, and a 4-week follow-up. Primary endpoints were the improvement rates of reflux and heartburn symptoms and VAS score changes. Secondary endpoints included atypical symptom scores, total TCM syndrome scores, GERD Health-Related Quality-of-Life (HRQL), and self-rated depression and anxiety scales. Safety assessments involved routine blood, urine, and liver and kidney function tests.ResultsAfter 4 weeks, the improvement rate for reflux or heartburn symptoms was 79.49% in the JQ group vs. 58.97% in the placebo group (P < 0.05). VAS scores showed significant reductions in both groups but without notable inter-group differences. Total TCM syndrome scores significantly decreased in both groups, with the JQ group showing greater improvement trends. The JQ group had higher rates of effective TCM syndrome improvement and better GERD-HRQL scores. Both groups saw significant reductions in self-rated depression and anxiety scores, with trends favoring JQ granules. Safety assessments were comparable between groups.ConclusionJQ granules significantly outperform placebo in treating NERD symptoms and display long-term effectiveness. They effectively address spleen deficiency and damp-heat syndrome, improving patients' social functioning, and have a favorable safety profile.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT04324138?term=NCT04324138&rank=1, identifier: NCT04324138.

Dataset Information

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

Background

Aim

Methods

Results

Conclusions

Publications

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

Similar Datasets

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