Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy

Kaohsiung Veterans General Hospital.248 enrolled

Overview

Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.

A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

248

Conditions

Helicobacter Pylori Infection

Interventions

(dexlan+amox+clar+metr)+(dexlan+amox)DRUG

a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily

dexlan+clarith+amox+metroDRUG

dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis Exclusion Criteria: * previous H pylori-eradication therapy * ingestion of antibiotics or bismuth within the prior 4 weeks * patients with allergic history to the medications used * patients with previous gastric surgery * the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia) * pregnant women

Locations (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

Number of Participants in Which H. Pylori Was Eradicated

To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.

Time frame: sixth week after the end of anti- H. pylori therapy

Data from ClinicalTrials.gov

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