|Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial|
|Wang, Ling1; Zhou, Liya2; Hu, Haitang3; Lin, Sanren2; Xia, Jielai1|
|关键词||Acid Suppression Cyp2c19 Duodenal Ulcer Ilaprazole Non-inferiority Ppi|
|刊名||CURRENT MEDICAL RESEARCH AND OPINION|
|WOS标题词||Science & Technology|
|类目[WOS]||Medicine, General & Internal ; Medicine, Research & Experimental|
|研究领域[WOS]||General & Internal Medicine ; Research & Experimental Medicine|
|关键词[WOS]||PROTON PUMP INHIBITORS ; GASTROESOPHAGEAL-REFLUX DISEASE ; HELICOBACTER-PYLORI INFECTION ; PEPTIC-ULCER ; OMEPRAZOLE ; POLYMORPHISM ; PANTOPRAZOLE ; RABEPRAZOLE ; RANITIDINE ; METABOLISM|
The new proton pump inhibitor (PPI), ilaprazole performed better at the dose of 10 mg/d relative to 5 or 20 mg/d in a previous phase II trial. A larger phase III trial was carried out to confirm the efficacy and safety of ilaprazole (10 mg/d) compared with omeprazole (20 mg/d) and provide some characteristics of the relationship between ilaprazole metabolism and CYP2C19 for later studies.
Research design and methods:
Patients with at least one endoscopically diagnosed active duodenal ulcer (DU) were enrolled in a multicenter, randomized, double-blind, positive controlled trial and then assigned randomly to the ilaprazole group (10 mg/d) or the omeprazole group (20 mg/d) with a sample allocation ratio 2:1. The course of treatment was 4 weeks.
Clinical trial registration:
ClinicalTrials.gov registration number: NCT00952978.
Main outcome measures:
The primary endpoint was endoscopically diagnosed ulcer healing rate at week 4. Symptom relief was evaluated as a secondary endpoint by graded scores. Safety and tolerability were evaluated on basis of clinical assessments. In addition, blood samples were collected at baseline for CYP2C19 genotypes identification.
Efficacy analyses were based on 494 patients. At week 4, the ulcer healing rates were 93.0% in ilaprazole group and 90.8% in omeprazole group (rate difference: 2.2%; 95% confidence interval: -2.8% to 7.2%). No obvious variation of healing rate on different CYP2C19 genotypes was found in ilaprazole group. The majority of patients (>80%) became asymptomatic after treatment. Incidences of adverse drug reactions were similar between ilaprazole group and omeprazole group (8.5% vs. 11.5%).
Ilaprazole (10 mg/d) is as effective as omeprazole (20 mg/d) in the treatment of DU with similar side effects. The efficacy of ilaprazole is not affected by CYP2C19 polymorphisms.
|资助机构||Livzon Pharmaceutical Group Inc. (China)|
|作者单位||1.Livzon Pharmaceut Inst, Zhuhai, Guangdong, Peoples R China|
2.Fourth Mil Med Univ, Dept Hlth Stat, Xian 710032, Shaanxi, Peoples R China
3.Peking Univ Third Hosp, Dept Gastroenterol, Beijing, Peoples R China
|Wang, Ling,Zhou, Liya,Hu, Haitang,et al. Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial[J]. CURRENT MEDICAL RESEARCH AND OPINION,2012,28(1):101-109.|
|APA||Wang, Ling,Zhou, Liya,Hu, Haitang,Lin, Sanren,&Xia, Jielai.(2012).Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial.CURRENT MEDICAL RESEARCH AND OPINION,28(1),101-109.|
|MLA||Wang, Ling,et al."Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial".CURRENT MEDICAL RESEARCH AND OPINION 28.1(2012):101-109.|