北京大学医学部机构知识库
Advanced  
IR@PKUHSC  > 北京大学第三临床医学院  > 消化科  > 期刊论文
学科主题: 临床医学
题名:
Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial
作者: 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
发表日期: 2012
DOI: 10.1185/03007995.2011.639353
卷: 28, 期:1, 页:101-109
收录类别: SCI
文章类型: Article
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
英文摘要:

Objective:

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.

Results:

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%).

Conclusions:

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.

语种: 英语
项目资助者: Livzon Pharmaceutical Group Inc. (China)
WOS记录号: WOS:000299284800012
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/57869
Appears in Collections:北京大学第三临床医学院_消化科_期刊论文

Files in This Item:

There are no files associated with this item.


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

Recommended Citation:
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.
Service
Recommend this item
Sava as my favorate item
Show this item's statistics
Export Endnote File
Google Scholar
Similar articles in Google Scholar
[Wang, Ling]'s Articles
[Zhou, Liya]'s Articles
[Hu, Haitang]'s Articles
CSDL cross search
Similar articles in CSDL Cross Search
[Wang, Ling]‘s Articles
[Zhou, Liya]‘s Articles
[Hu, Haitang]‘s Articles
Related Copyright Policies
Null
Social Bookmarking
Add to CiteULike Add to Connotea Add to Del.icio.us Add to Digg Add to Reddit

Items in IR are protected by copyright, with all rights reserved, unless otherwise indicated.

 

 

Valid XHTML 1.0!
Copyright © 2007-2017  北京大学医学部 - Feedback
Powered by CSpace