Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

Not Applicable

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Tegoprazan; Drug: Lansoprazole

• Registration Number: NCT04674774
• Lead Sponsor: Incheon St.Mary's Hospital

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.

Study Timeline

• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Study Start: 2021-03-04
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-10
• Primary Completion: 2022-02-28
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 217

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tegoprazan based bismuth quadruple therapy group	Tegoprazan	tegoprazan based bismuth quadruple therapy group
PPI based bismuth quadruple therapy group	Lansoprazole	PPI based bismuth quadruple therapy group

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate of each group	UBT test 4 weeks after completion of eradication treatment	H. pylori eradication rate of each group

Trial Locations

Locations (1)

Incheon St. Mary's Hospital; 🇰🇷 Incheon, Korea, Republic of