Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT

Phase 3

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: RAPAE01; Drug: Tegoprazan

• Registration Number: NCT04128917
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-16
• Study Start: 2020-01-21
• Primary Completion: 2020-12-21
• Study Completion: 2021-01-29
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAPAE01	RAPAE01	RAPAE01 Triple Therapy
Tegoprazan 100 mg	Tegoprazan	Tegoprazan 100 mg Triple Therapy
Tegoprazan 50 mg	Tegoprazan	Tegoprazan 50 mg Triple Therapy

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate	Day 49	Assess H. pylori eradication rate by UBT

Trial Locations

Locations (1)

Chung-Ang University Hosptial; 🇰🇷 Seoul, Korea, Republic of