Abstract | AIM AND BACKGROUND: METHODS: This study used a randomized, double-blind, parallel positive drug control, multi-center design. A total of 537patients diagnosed as reflux esophagitis by gastroscopy were randomly divided into Ilaparazole group (n = 322, Ilaparazole 10 mg QD) and esomeprazole group (n = 215, Esomeprazole 40 mg QD). The patients in the two groups were treated for 8 weeks. Heartburn and reflux symptoms prior to treatment, and 2, 4 and 8 weeks after the treatment were assessed. Gastroscopy was performed after 4 weeks of treatment. Unhealed patients within 4 weeks underwent gastroscopy again at the end of 8 weeks. RESULTS: A total of 471 cases completed the treatment. In Esomeprazole and Ilaparazole groups. After 8 weeks treatment, the healing rate in Esomeprazole group and Ilaparazole group were 82.79% (94.94%) and 83.54% (92.50%), respectively. The corresponding rate difference [Ilaparazole- esomeprazole] was 0.75% (-2.44%) and the two-sided 95% CI was -5.72 to 7.22 (-6.90 to 2.01). The symptom disappearance rates for FAS (PPS) were 75.81% (82.02%) and 76.71% (80.36%) P = 0.8223 (0.7742). Adverse reactions related to the drugs were: 10.70% and 11.80%, (P = 0.7817). CONCLUSIONS: The efficacy and safety of Ilaparazole (10 mg/day) in treating reflux esophagitis was similar to esomeprazole (40 mg/day). Ilaparazole (10 mg/day) can be used in the treatment of esophagitis. The clinical trial registration number of the study is NCT 02860624.
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Authors | Yan Xue, Xianghong Qin, Liya Zhou, Sanren Lin, Ling Wang, Haitang Hu, Jielai Xia |
Journal | Contemporary clinical trials
(Contemp Clin Trials)
Vol. 68
Pg. 67-71
(05 2018)
ISSN: 1559-2030 [Electronic] United States |
PMID | 29540336
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2018. Published by Elsevier Inc. |
Chemical References |
- 2-Pyridinylmethylsulfinylbenzimidazoles
- Proton Pump Inhibitors
- ilaprazole
- Esomeprazole
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Topics |
- 2-Pyridinylmethylsulfinylbenzimidazoles
(administration & dosage, adverse effects)
- Adult
- Double-Blind Method
- Drug Monitoring
(methods)
- Esomeprazole
(administration & dosage, adverse effects)
- Esophagitis, Peptic
(diagnosis, drug therapy, physiopathology)
- Female
- Gastroscopy
(methods)
- Humans
- Male
- Middle Aged
- Proton Pump Inhibitors
(administration & dosage, adverse effects)
- Symptom Assessment
(methods)
- Treatment Outcome
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