Helicobacter Pylori Infection
Conditions
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.
Interventions
DRUGTegoprazan 50 mg Triple Therapy
Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
DRUGTegoprazan 100 mg Triple Therapy
Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
DRUGLansoprazole Triple Therapy
Lansoprazole/Clarithromycin/ Amoxicillin BID peroral, 14 days
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| H. pylori eradication rate | 42 days | Assess H. pylori eradication rate by UBT |
Countries
South Korea
Contacts
Primary ContactEun Ji Kim
Backup ContactHee Hyun Kim
Outcome results
None listed