Effects of Ilaprazole on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone ESD.

Phase 4 Completed 176 enrolled Il-Yang Pharm. Co., Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and investigated Prevention of gastrointestinal bleeding.

Timeline

Start: 2015-12
Primary completion: 2018-03
Completion: 2018-03

Outcome

Missed primary endpoint

paper There was no significant difference in the ulcer healing rate (ilaprazole vs. rabeprazole, 97.4% vs. 97.0 p = 0.78 at 4 weeks PMID 30167954 ↗

paper 100% vs. 100%, p = 0.95 at 8 weeks in the mITT analysis PMID 30167954 ↗

Publications

Bang CS, Shin WG, Seo SI, Choi MH, Jang HJ, Park SW, Kae SH, Yang YJ, Shin SP, Baik GH, Kim HY. Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study. Surg Endosc. 2019 May;33(5):1376-1385. doi: 10.1007/s00464-018-6412-9. Epub 2018 Aug 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ilaprazole	Small molecule	20 mg	Oral
Comparator	Rabeprazole	Small molecule	20 mg	Oral