Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

Incheon St.Mary's Hospital

Status: Unknown

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Lansoprazole; Drug: Tegoprazan

Study type: Interventional

Funder types: Other

Identifiers

NCT04674774

OC20MIDI0057

Details and patient eligibility

About

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)

Full description

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

Enrollment: 217 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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217 participants in 2 patient groups

tegoprazan based bismuth quadruple therapy group

Experimental group

Description:

tegoprazan based bismuth quadruple therapy group

Treatment:

Drug: Tegoprazan

PPI based bismuth quadruple therapy group

Active Comparator group

Description:

PPI based bismuth quadruple therapy group

Treatment:

Drug: Lansoprazole