Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: dexlan+clarith+amox+metro; Drug: (dexlan+amox+clar+metr)+(dexlan+amox)

• Registration Number: NCT02646332
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Primary Completion: 2020-07-31
• Study Completion: 2020-08-31
• Status Verified: 2020-11
• Results First Submitted: 2020-11-01
• Results First Submitted QC: 2020-11-01
• Last Update Submitted: 2020-11-01
• Results First Posted: 2020-11-24
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexlan+clarith+amox+metro	dexlan+clarith+amox+metro	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
(dexlan+amox+clar+metr)+(dexlan+amox)	(dexlan+amox+clar+metr)+(dexlan+amox)	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

Primary Outcome Measures

Name	Time	Method
Number of Participants in Which H. Pylori Was Eradicated	sixth week after the end of anti- H. pylori therapy	To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan