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Clinical Drug Investigation
Published in: Clinical Drug Investigation 12/2016

01-12-2016 | Original Research Article

A Randomized, Double-blind, Active-Controlled, Multi-center Study of Ilaprazole in the Treatment of Reflux Esophagitis

Authors: Yan Xue, Xianghong Qin, Liya Zhou, Sanren Lin, Ling Wang, Haitang Hu, Jielai Xia

Published in: Clinical Drug Investigation | Issue 12/2016

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Abstract

Background and Objective

Proton pump inhibitors (PPIs) are the main drugs for the treatment of reflux esophagitis. Previous studies have indicated ilaprazole to be safer and more effective in treating duodenal ulcers as compared with omeprazole. Being a novel PPI, ilaprazole may be used in the treatment of reflux esophagitis. The purpose of this study was to evaluate the safety and efficacy of ilaprazole tablets in the treatment of reflux esophagitis.

Methods

This study used a randomized, double-blind, multi-center, active-comparison design. The patients were randomly divided into an ilaprazole group (10 mg once daily and 15 mg once daily) and an esomeprazole group (40 mg once daily). Both the groups were treated for 8 weeks. Heartburn and reflux symptoms prior to treatment, and 4 and 8 weeks after the treatment were assessed. Gastroscopy was performed after 4 and 8 weeks. The healing rate after 4 weeks treatment was compared. If esophagitis was healed at the end of 4 weeks, patients did not undergo gastroscopy at the end of 8 weeks.

Results

Three hundred and twenty-five patients were enrolled in this study. The 4-week full analysis set (per-protocol set) healing rates in the esomeprazole 40-mg group, the ilaprazole 10-mg group, and the ilaprazole 15-mg group were: 71.43 % (78.89 %), 81.31 % (86.73 %), and 71.70 % (81.40 %), respectively, p = 0.1595 (0.4122); the 8-week healing rates were 84.76 % (93.33 %), 88.79 % (94.90 %), and 85.85 % (97.67 %), respectively, p = 0.6689 (0.4049). Drug-related adverse events rate were 10.48 %, 14.02 %, and 15.09 %, respectively, in the three groups (p = 0.6114).

Conclusion

The efficacy and safety of ilaprazole (10 mg/day, 15 mg/day) in treating reflux esophagitis was similar to esomeprazole (40 mg/day). Ilaprazole (10 mg/day) has a smaller dosage, hence it should be considered more in clinical uses.
Trial registration: ClinicalTrials.gov NCT01107938.
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Metadata
Title
A Randomized, Double-blind, Active-Controlled, Multi-center Study of Ilaprazole in the Treatment of Reflux Esophagitis
Authors
Yan Xue
Xianghong Qin
Liya Zhou
Sanren Lin
Ling Wang
Haitang Hu
Jielai Xia
Publication date
01-12-2016
Publisher
Springer International Publishing
Published in
Clinical Drug Investigation / Issue 12/2016
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.1007/s40261-016-0446-3

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