Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients
Phase 2
Recruiting
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT05933031
- Lead Sponsor
- HK inno.N Corporation
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 381
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 Tegoprazan 50 mg Tegoprazan 50 mg Triple Therapy Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days Tegoprazan 100 mg Tegoprazan 100 mg Triple Therapy Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days Lansoprazole Lansoprazole Triple Therapy Lansoprazolee/Clarithromycin/ Amoxicillin BID peroral, 14 days
- Primary Outcome Measures
Name Time Method H. pylori eradication rate 42 days Assess H. pylori eradication rate by UBT
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chung-Ang University Hosptial
🇰🇷Seoul, Korea, Republic of