Evidence map›Paper›PMID 27605258›Full record

Trial reportClinical drug investigation2016

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

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

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01107938 (Efficacy and Safety of Ilaprazole for GERD), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01107938 phase2unknown statusnot on this map

Efficacy and Safety of Ilaprazole for GERD: A Randomized,Double-Blind, Esomeprazole-Controlled,Phase2,Multicenter Trial in China

TypeinterventionalSponsorLivzon Pharmaceutical Group Inc.Ran2010Enrolled330ConditionsGastroesophageal Reflux DiseaseArms10 mg ilaprazole, 15 mg ilaprazole, 40 mg esomeprazole
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Yan XueDepartment of Gastroenterology, Peking University Third Hospital Beijing, 49, Huayuan North Road, Haidian District, Beijing, 100191, China.
Xianghong QinLivzon Pharmacertical Group Inc., Zhuhai, Guangdong, China.
Liya ZhouDepartment of Gastroenterology, Peking University Third Hospital Beijing, 49, Huayuan North Road, Haidian District, Beijing, 100191, China. zhoumed@126.com.
Sanren LinDepartment of Gastroenterology, Peking University Third Hospital Beijing, 49, Huayuan North Road, Haidian District, Beijing, 100191, China.
Ling WangThe Fourth Military Medical University, Xi'an, Shanxi, China.
Haitang HuLivzon Pharmacertical Group Inc., Zhuhai, Guangdong, China.
Jielai XiaThe Fourth Military Medical University, Xi'an, Shanxi, China.
Air Force Medical University · CNPeking University Third Hospital · CNPeking University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveProton 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.

methodsThis 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.

resultsThree 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).

conclusionThe 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 registrationClinicalTrials.gov NCT01107938.

Indexed as

2-PyridinylmethylsulfinylbenzimidazolesAdultDouble-Blind MethodEsomeprazoleEsophagitis, PepticFemaleHeartburnHumansMaleMiddle AgedProton Pump Inhibitors2-PyridinylmethylsulfinylbenzimidazolesEsomeprazoleilaprazoleProton Pump Inhibitors

Identifiers

PMID27605258
OpenAlexW2512732404

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.