Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT

HK inno.N

Status and phase: Completed; Phase 3

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Tegoprazan; Drug: RAPAE01

Study type: Interventional

Funder types: Industry

Identifiers

NCT04128917

CJ_APA_E01

Details and patient eligibility

About

This study aims to compare safety and efficacy in an exploratory manner between a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.

Full description

A Randomized, Double-Blind, Active-controlled, Multicenter, Pilot Study to Investigate the Safety and Efficacy of a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.

Enrollment: 102 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

---

102 participants in 3 patient groups

Tegoprazan 50 mg

Experimental group

Description:

Tegoprazan 50 mg Triple Therapy

Treatment:

Drug: Tegoprazan

Tegoprazan 100 mg

Experimental group

Description:

Tegoprazan 100 mg Triple Therapy

Treatment:

Drug: Tegoprazan

RAPAE01

Active Comparator group

Description:

RAPAE01 Triple Therapy

Treatment:

Drug: RAPAE01