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

NCT03317223 | Completed Phase 3

• 1 other identifier: CJ_APA_306
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rate

  Subjects will be considered to succeed in achieving H. pylori eradication if subject's UBT test (Eradication Assessment)

  twice a day

Study Arms (2)

CJ-12420/Clarithromycin/Amoxicillin

EXPERIMENTAL

CJ-12420 50mg /Clarithromycin 500mg /Amoxicillin 1g

Drug: CJ-12420/Clarithromycin/Amoxicillin

Lansoprazole/Clarithromycin/Amoxicillin

ACTIVE COMPARATOR

Lansoprazole 30mg /Clarithromycin 500mg /Amoxicillin 1g

Drug: CJ-12420/Clarithromycin/Amoxicillin

Interventions

CJ-12420/Clarithromycin/Amoxicillin DRUG

CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days

Also known as: Lansoprazole/Clarithromycin/Amoxicillin

CJ-12420/Clarithromycin/Amoxicillin; Lansoprazole/Clarithromycin/Amoxicillin

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• H. pylori-positive at screening
• Complain of gastric discomfort symptom

You may not qualify if:

• Having received prior therapy for eradication of H. pylori
• Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days
• Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Yonsei University Severance Hospital

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 35791797 DERIVED

MeSH Terms

Interventions

Lansoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yong Chan Lee

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: October 17, 2017
• Primary Completion: January 21, 2019
• Study Completion: January 24, 2019
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)