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Clinical trial

Efficacy of Tegoprazan-containing Sequential Therapy Compared to Proton Pump Inhibitor-based Eradication in South Korea, a Region With High Antimicrobial Resistance: A Prospective Randomized Single Tertiary Center Study

ID
Name
B-2011-648-005
Description
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
Trial arms
Trial start
2021-02-01
Estimated PCD
2024-12-12
Trial end
2024-12-12
Status
Recruiting
Treatment
Tegoprazan-containing sequential H. pylori eradication therapy
tegoprazan was administered, instead propton-pump inhibitor, as acid blockade in H. pylori eradication sequential therapy
Arms:
Tegoprazan-containing sequential H. pylori eradication therapy (experimental method)
Esomeprazole-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)
Arms:
Esomeprazole-containing sequential H. pylori eradication therapy (conventional method)
Size
400
Primary endpoint
Eradication rate
2 or 3 month
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}
Updated at
2024-05-02

1 organization

2 products

1 indication

Organization
Seoul National University Bundang Hospital
Product
Tegoprazan
Indication
Helicobacter pylori infection
Product
Esomeprazole