NCT05453994

Completed

Bismuth for PCAB-based H. Pylori Eradication

Soonchunhyang University Hospital Source

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Other study identifiers

Sponsor study identifier

SCH-HP-2022

Study Type

observational

Actual enrollment (reported)

150

Locations

1 country

Sites

1

Timeline

Study Start

March 1, 2020

Actual (reported)

Primary Completion

August 31, 2023

Actual (reported)

Study Completion

August 31, 2023

Actual (reported)

Brief Summary

Tegoprazan is a new potassium-competitive acid blocker (PCAB) that has been clinically available since 2018 in South Korea. P-CAB is highly active drugs targeting H+, K+ -ATPase in the gastric acid secretion of parietal cells. The mechanism of action is different from that of PPIs. Conventional PPIs require 3-5 days to achieve maximal and steady-state gastric acid inhibition, whereas P-CAB increases the intragastric pH to nearly 7 within four hours. In Japan, H. pylori eradication success rates has increased by therapies using P-CAB than those using proton pump inhibitors, owing to the stronger acid suppression capability of P-CAB. Bismuth has long been used to treat peptic ulcer disease, dyspepsia, parasite infections, and infectious diarrhea. The antibacterial effects of bismuth include inhibition of protein and cell wall synthesis in H. pylori. The main role of bismuth is to increase the eradication rate by 30%-40% in resistant H. pylori strains.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 150 participants
Study completion date: August 31, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 1, 2020
Actual (reported)
First Submitted
July 6, 2022
Actual (reported)
First Posted
July 12, 2022
Actual (reported)
Primary Completion
August 31, 2023
Actual (reported)
Study Completion
August 31, 2023
Actual (reported)

Last Updated: November 22, 2023
Status Verified: November 2023
Last Update Submitted: November 20, 2023

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

H. pylori infection status
Rate of successful H. pylori eradication
6 weeks

Study Arms (2)

Non-bismuth group

Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid for 14 days

Drug: H. pylori eradication

Bismuth group

Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days

Drug: H. pylori eradication

Interventions

H. pylori eradicationDrug

PPIs-based Antimicrobial agents for H. pylori eradication

Bismuth groupNon-bismuth group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

H. pylori-infected patients

You may qualify if:

Gastroscopy can be performed

Sponsors & Collaborators

Soonchunhyang University Hospital
Otherlead

Study Sites (1)

Digestive Disease Center, Soonchunhyang University Hospital

Seoul, 04401, South Korea

Related Publications (1)

Cho JH. Bismuth add-on improves the efficacy of 2-week tegoprazan-based triple therapy for first-line Helicobacter pylori eradication: a real-world evidence study. Expert Rev Anti Infect Ther. 2024 Sep;22(9):793-799. doi: 10.1080/14787210.2024.2329251. Epub 2024 Mar 13.
PMID: 38459869DERIVED

Study Officials

Jun-Hyung Cho, M.D.
Soonchunhyang University Hospital
PRINCIPAL INVESTIGATOR

Enrollment

150 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 12, 2022

Study Start

March 1, 2020

Actual (reported)

NCT06045832

Oral Helicobacter Pylori Eradication

Not ApplicableUnknown

NCT04713670

Comparison of Vonoprazan-based Versus Lansoprazole-based Triple Therapy, High Dose Dual Therapy, Bismuth and Non-bismuth Quadruple Therapy in the First-line Treatment of Helicobacter Pylori Infection

Phase 4Recruiting

NCT03555526

Genotypic Resistance Guided Therapy for Refractory H. Pylori Infection

Phase 4Unknown

NCT03340454

Patient-Centered Cancer Prevention In Chinese Americans

Not ApplicableCompleted

NCT06304532

Clinical Efficacy and Safety Assessment of Alsareen Capsule for the Management of H. Pylori Infection

Completed

NCT06050824

A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection

Phase 4Completed

H. pylori test and pathological analysis can be performed

You may not qualify if:

Age \< 20 or \> 80 years
Anemia (serum hemoglobin level \< 10 g/dL)
Severe systemic disease
Advanced chronic liver disease
Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
History of H. pylori eradication
Drug allergy to antibiotics
History of gastric surgery
Recent history of upper gastrointestinal bleeding

Contact the study team to confirm eligibility.

Primary Completion

August 31, 2023

Actual (reported)

Study Completion

August 31, 2023

Actual (reported)

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05453994
Data provider: ClinicalTrials.gov
Source updated: 2023-11-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:30 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Non-bismuth group

Bismuth group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations