Helicobacter Pylori Infection
Conditions
Brief summary
As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy
Detailed description
Eradication treatment containing potassium-competitive acid blocker has shown acceptable eradication efficacy. In regions such as Korea, where the prevalence of antimicrobial resistance is high, alternative combinations of antibiotics such as sequential or concomitant therapy are needed. This study compared the outcome of sequential therapy containing tegoprazan, a new potassium-competitive acid blocker, with the conventional esomeprazole-containing sequential therapy.
Interventions
DRUGTegoprazan-containing sequential H. pylori eradication therapy
tegoprazan was administered, instead propton-pump inhibitor, as acid blockade in H. pylori eradication sequential therapy
DRUGEsomeprazole-containing sequential H. pylori eradication therapy
Esomeprazole was administered as acid blockade in H. pylori eradication sequential therapy (conventional acid blockade method for sequential eradication therapy)
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients who had H. pylori infection proved by positive test result of urea breath test (UBT), rapid urase test or pathologic examination (warthin-giemsa staining)
Exclusion criteria
* congestive heart failure, NYHA III or IV * end-stage renal disease * alcoholics * drug abusers * pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate | 2 or 3 month | Efficacy of H. pylori eradication therapy. confirmed by negative UBT test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | up to 6 month | any adverse events occured during or after intervention (eradication therapy) |
Countries
South Korea
Contacts
CONTACTJungwon Lee, Dr.
PRINCIPAL_INVESTIGATORNayoung Kim, Prof.
Seoul National University Bundang Hospital
Outcome results
None listed