Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients

HK inno.N

Status and phase: Enrolling; Phase 2

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Lansoprazole Triple Therapy; Drug: Tegoprazan 50 mg Triple Therapy; Drug: Tegoprazan 100 mg Triple Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05933031

IN_APA_E02

Details and patient eligibility

About

This exploratory study is designed to compare safety and efficacy between a Tegoprazan dose-specific standard triple therapy and Lansoprazole standard triple therapy in H. pylori positive patients.

Full description

A Randomized, Double-Blind, Active-controlled, Multicenter, Therapeutic Exploratory Study to to Evaluate the Safety and Efficacy of a Standard Triple Therapy with Tegoprazan and Lansoprazole standard triple therapy in H. pylori Positive Patients, twice a day for 14 days.

Enrollment: 381 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• H. pylori positive at screening
• Subjects who have upper gastrointestinal disease

Exclusion criteria

• Having received prior therapy for eradication of H. pylori
• Prior use of P-CAB, proton pump inhibitors (PPIs), H2 receptor blockers within 14 days
• Prior use of H. pylori eradication effective antibiotics, bismuth within 28 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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381 participants in 3 patient groups

Tegoprazan 50 mg

Experimental group

Description:

Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days

Treatment:

Drug: Tegoprazan 50 mg Triple Therapy

Tegoprazan 100 mg

Experimental group

Description:

Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days

Treatment:

Drug: Tegoprazan 100 mg Triple Therapy

Lansoprazole

Active Comparator group

Description:

Lansoprazolee/Clarithromycin/ Amoxicillin BID peroral, 14 days

Treatment:

Drug: Lansoprazole Triple Therapy