N/A N=390 Randomized Treatment

Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

Helicobacter Pylori Infection

Bottom Line

View on ClinicalTrials.gov: NCT02159976 ↗

Enrolled (actual)

390

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Counts of Participants With Successful H. Pylori Eradication — 146; 134 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pantoprazole (Drug); Amoxicillin (Drug); Clarithromycin (Drug); Metronidazole (Drug); Tetracycline (Drug); Bismuth (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Seoul National University Bundang Hospital
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Counts of Participants With Successful H. Pylori Eradication	146; 134	—
SECONDARY Counts of Participants Whose Drug Compliance is More Than 85%	165; 170	—
SECONDARY Counts of Participants With Adverse Event	93; 72	—
SECONDARY Functional Dyspepsia Symptom Responses Rate	44; 0; 1; 0; 6; 1	—

Summary

1. To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea. 2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia

Eligibility Criteria

Inclusion Criteria

Male and female Korean Adult (Aged ≥ 18 years)
Patients who diagnosis of H. pylori infection by any of following three methods
positive rapid urease test (CLOtest)
histologic evidence of H. pylori by modified Giemsa staining
positive 13C-urea breath test

Exclusion Criteria

Age under 18 years
Previous eradication treatment for H. pylori
Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
History of gastrectomy
Advanced gastric cancer or other malignancy
Abnormal liver function or liver cirrhosis
Abnormal renal function or chronic kidney disease
Other severe concurrent diseases
Previous allergic reactions to the study drugs
Pregnant or lactating women

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Data sourced from ClinicalTrials.gov (NCT02159976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.