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Adding Bismuth to Rabeprazole-based First-line Triple Therapy Does Not Improve the Eradication of Helicobacter Pylori

NCT03108287 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2017-04-24

No results posted yet for this study

Summary

This randomized controlled study aimed to evaluate whether adding bismuth to the standard first-line triple therapy could improve the eradication rate of Helicobacter pylori (H. pylori). A total of 162 patients with H. pylori infection were randomly assigned to either the 7-day triple therapy group (n = 81) or the bismuth plus triple therapy group (n = 81). The triple therapy (RAK) contained the twice-daily dosage of rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg. In the RBAK group, bismuth subcitrate 360 mg twice daily was added to the RAK regimen.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

RAK therapy

rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg twice-daily

DRUG

RBAK therapy

rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg, bismuth subcitrate 360mg twice-daily

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Principal Investigators

  • I-Chen Wu, MD, PhD · Kaohsiung Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-01
Primary Completion
2015-01-31
Completion
2015-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03108287 on ClinicalTrials.gov