N/A
Completed N=390
Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea
Source: ClinicalTrials.gov NCT02159976 ↗Enrolled (actual)
390
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Counts of Participants With Successful H. Pylori Eradication — 146; 134 Participants
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
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 | — |
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
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. Informational only — not medical advice.