Abstract | BACKGROUND AND OBJECTIVE: 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: TRIAL REGISTRATION: ClinicalTrials.gov NCT01107938.
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Authors | Yan Xue, Xianghong Qin, Liya Zhou, Sanren Lin, Ling Wang, Haitang Hu, Jielai Xia |
Journal | Clinical drug investigation
(Clin Drug Investig)
Vol. 36
Issue 12
Pg. 985-992
(Dec 2016)
ISSN: 1179-1918 [Electronic] New Zealand |
PMID | 27605258
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- 2-Pyridinylmethylsulfinylbenzimidazoles
- Proton Pump Inhibitors
- ilaprazole
- Esomeprazole
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Topics |
- 2-Pyridinylmethylsulfinylbenzimidazoles
(therapeutic use)
- Adult
- Double-Blind Method
- Esomeprazole
(therapeutic use)
- Esophagitis, Peptic
(drug therapy)
- Female
- Heartburn
(drug therapy)
- Humans
- Male
- Middle Aged
- Proton Pump Inhibitors
(administration & dosage, therapeutic use)
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