Back to resultsExploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients
Primary Purpose
Helicobacter Pylori Infection
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tegoprazan 50 mg Triple Therapy
Tegoprazan 100 mg Triple Therapy
Lansoprazole Triple Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection
Eligibility Criteria
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
Sites / Locations
- Chung-Ang University HosptialRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Tegoprazan 50 mg
Tegoprazan 100 mg
Lansoprazole
Arm Description
Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Lansoprazolee/Clarithromycin/ Amoxicillin BID peroral, 14 days
Outcomes
Primary Outcome Measures
H. pylori eradication rate
Assess H. pylori eradication rate by UBT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05933031
Brief Title
Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients
Official Title
A Randomized, Double-Blind, Active-controlled, Multi-center, Therapeutic Exploratory Study to Evaluate the Safety and Efficacy of a Standard Triple Therapy With Tegoprazan (by Dose) in H. Pylori Positive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HK inno.N Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
381 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tegoprazan 50 mg
Arm Type
Experimental
Arm Description
Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Arm Title
Tegoprazan 100 mg
Arm Type
Experimental
Arm Description
Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Arm Title
Lansoprazole
Arm Type
Active Comparator
Arm Description
Lansoprazolee/Clarithromycin/ Amoxicillin BID peroral, 14 days
Intervention Type
Drug
Intervention Name(s)
Tegoprazan 50 mg Triple Therapy
Intervention Description
Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Intervention Type
Drug
Intervention Name(s)
Tegoprazan 100 mg Triple Therapy
Intervention Description
Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Intervention Type
Drug
Intervention Name(s)
Lansoprazole Triple Therapy
Intervention Description
Lansoprazole/Clarithromycin/ Amoxicillin BID peroral, 14 days
Primary Outcome Measure Information:
Title
H. pylori eradication rate
Description
Assess H. pylori eradication rate by UBT
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Ji Kim
Phone
82-2-6477-0290
Email
eunji.kim24@inno-n.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Hyun Kim
Phone
82-2-6477-0258
Email
heehyun.kim@inno-n.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Gyu Kim
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung-Ang University Hosptial
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients
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