A Phase 3 Study to Evaluate the Efficacy and Safety of Triple Therapy With CJ-12420 in H. Pylori Positive Patients

Phase 3 Completed 350 enrolled HK inno.N Corporation

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The current study is designed to demonstrate the non-inferiority of CJ-12420-based triple therapy (CJ-12420, amoxicillin and clarithromycin) versus lansoprazole-based triple therapy (lansoprazole, amoxicillin and clarithromycin) in H. pylori eradication rate and to evaluate the safety of CJ-12420 following oral administration of either triple therapy twice daily for 7 days in H. pylori positive patients.

Timeline

Start: 2017-10-17
Primary completion: 2019-01-21
Completion: 2019-01-24

Publications

Choi YJ, Lee YC, Kim JM, Kim JI, Moon JS, Lim YJ, Baik GH, Son BK, Lee HL, Kim KO, Kim N, Ko KH, Jung HK, Shim KN, Chun HJ, Kim BW, Lee H, Kim JH, Chung H, Kim SG, Jang JY. Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial. Gut Liver. 2022 Jul 15;16(4):535-546. doi: 10.5009/gnl220055. Epub 2022 Jul 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lansoprazole	Other / unclassified	30 mg	Oral
Subject	Tegoprazan	Other / unclassified	50 mg	—
Background	Amoxicillin	Other / unclassified	1 g	Oral
Background	Clarithromycin	Small molecule	500 mg	Oral

A Phase 3 Study to Evaluate the Efficacy and Safety of Triple Therapy With CJ-12420 in H. Pylori Positive Patients

Summary

Timeline

Publications

Drugs

Indications