Tegoprazan-containing Sequential for H. Pylori

Not Applicable

Recruiting

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Esomeprazole-containing sequential H. pylori eradication therapy; Drug: Tegoprazan-containing sequential H. pylori eradication therapy

• Registration Number: NCT06382493
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy

Detailed Description

Eradication treatment containing potassium-competitive acid blocker has shown acceptable eradication efficacy. In regions such as Korea, where the prevalence of antimicrobial resistance is high, alternative combinations of antibiotics such as sequential or concomitant therapy are needed. This study compared the outcome of sequential therapy containing tegoprazan, a new potassium-competitive acid blocker, with the conventional esomeprazole-containing sequential therapy.

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-20
• Study First Submitted QC: 2024-04-20
• Study First Posted: 2024-04-24
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-02
• Primary Completion: 2024-12-12
• Study Completion: 2024-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients who had H. pylori infection proved by positive test result of urea breath test (UBT), rapid urase test or pathologic examination (warthin-giemsa staining)

Exclusion Criteria

• congestive heart failure, NYHA III or IV
• end-stage renal disease
• alcoholics
• drug abusers
• pregnant or nursing women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esomeprazole-containing sequential H. pylori eradication therapy (conventional method)	Esomeprazole-containing sequential H. pylori eradication therapy	esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days.
Tegoprazan-containing sequential H. pylori eradication therapy (experimental method)	Tegoprazan-containing sequential H. pylori eradication therapy	tegoprazan (50 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days.

Primary Outcome Measures

Name	Time	Method
Eradication rate	2 or 3 month	Efficacy of H. pylori eradication therapy. confirmed by negative UBT test

Secondary Outcome Measures

Name	Time	Method
Adverse events	up to 6 month	any adverse events occured during or after intervention (eradication therapy)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of