Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

Incheon St.Mary's Hospital217 enrolled

Overview

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)

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

217

Conditions

Helicobacter Pylori Infection

Interventions

TegoprazanDRUG

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

LansoprazoleDRUG

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Incheon St. Mary's Hospital

Incheon, South Korea

Outcomes

Primary Outcomes

H. pylori eradication rate of each group

Time frame: UBT test 4 weeks after completion of eradication treatment

Data from ClinicalTrials.gov

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