Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

Efficacy of Tegoprazan Based Bismuth Quadruple Therapy Compared With Bismuth Quadruple Therapy for Helicobacter Pylori Infection: Randomized, Double-blind, Active-Controlled Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04674774

Enrollment

217

Registered

2020-12-19

Start date

2021-03-04

Completion date

2022-03-31

Last updated

2022-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Brief summary

This study aims to investigate eradication rate, drug compliance, and adverse events in patients with confirmed Helicobacter pylori infection between tegoprazan, bismuth, metronidazole, and tetracycline for 14 days (TBMT) and PPI, bismuth, metronidazole, and tetracycline for 14 days (LBMT)

Detailed description

This is a multi-center, double-blind, randomized, active-controlled study.

Interventions

DRUGTegoprazan

oral administration of tegoprazan-based bismuth quadruple therapy(tegoprazan 50 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 days

DRUGLansoprazole

oral administration of PPI-based bismuth quadruple therapy(lansoprazole 30 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

Inclusion criteria

patients who male or female aged 19 to 75 years old and fall under the following conditions with confirmed helicobacter pylori infection

Exclusion criteria

1. patients who have H.pylori eradication history 2. patients with history of gastric cancer surgery 3. patients who have taken antibiotics within 4 weeks prior to trial 4. a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine 5. pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame	Description
H. pylori eradication rate of each group	UBT test 4 weeks after completion of eradication treatment	H. pylori eradication rate of each group

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026