Tegoprazan-containing Sequential for H. Pylori

Seoul National University

Status: Enrolling

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Esomeprazole-containing sequential H. pylori eradication therapy; Drug: Tegoprazan-containing sequential H. pylori eradication therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06382493

B-2011-648-005

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

Esomeprazole-containing sequential H. pylori eradication therapy (conventional method)

Active Comparator group

Description:

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.

Treatment:

Drug: Esomeprazole-containing sequential H. pylori eradication therapy

Tegoprazan-containing sequential H. pylori eradication therapy (experimental method)

Experimental group

Description:

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.

Treatment:

Drug: Tegoprazan-containing sequential H. pylori eradication therapy