- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04128917
Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT
May 10, 2021 updated by: HK inno.N Corporation
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Chung-Ang University Hosptial
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tegoprazan 50 mg
Tegoprazan 50 mg Triple Therapy
|
Tegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral
|
Experimental: Tegoprazan 100 mg
Tegoprazan 100 mg Triple Therapy
|
Tegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral
|
Active Comparator: RAPAE01
RAPAE01 Triple Therapy
|
RAPAE01/Clarithromycin/Amoxicillin BID peroral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
H. pylori eradication rate
Time Frame: Day 49
|
Assess H. pylori eradication rate by UBT
|
Day 49
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: JAEGYU KIM, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2020
Primary Completion (Actual)
December 21, 2020
Study Completion (Actual)
January 29, 2021
Study Registration Dates
First Submitted
October 15, 2019
First Submitted That Met QC Criteria
October 15, 2019
First Posted (Actual)
October 16, 2019
Study Record Updates
Last Update Posted (Actual)
May 12, 2021
Last Update Submitted That Met QC Criteria
May 10, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- CJ_APA_E01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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