Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-04

Study Completion Date

2022-03-31

Brief Summary

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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)

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Detailed Description

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

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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tegoprazan based bismuth quadruple therapy group

Group Type EXPERIMENTAL

Tegoprazan

Intervention Type DRUG

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

PPI based bismuth quadruple therapy group

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

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

Interventions

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Tegoprazan

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

Intervention Type DRUG

Lansoprazole

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No