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NCT04128917 Clinical Trial

Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT

Helicobacter Pylori Infection Clinical Trial

Official title:
A Randomized, Double-Blind, Active-controlled, Multicenter, Pilot Study to Investigate the Safety and Efficacy of a Triple Therapy With Tegoprazan, Amoxicillin and Clarithromycin in H. Pylori Positive Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04128917
Other study ID # CJ_APA_E01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 21, 2020
Est. completion date January 29, 2021

Study information
Verified date May 2021
Source HK inno.N Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date January 29, 2021
Est. primary completion date December 21, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tegoprazan
Tegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral
• RAPAE01
RAPAE01/Clarithromycin/Amoxicillin BID peroral

Locations
Country Name City State
Korea, Republic of Chung-Ang University Hosptial Seoul

Sponsors (1)
Lead Sponsor Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary H. pylori eradication rate Assess H. pylori eradication rate by UBT Day 49
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