Comparing the Efficacy of Reverse Hybrid Therapy and Bismuth Quadruple Therapy

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: (panto+amox+clar+metr)+(panto+amox); Drug: pantoprazole+bismuth+tetra+metro

• Registration Number: NCT02547038
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

Reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained 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 bismuth quadruple therapy remained unanswered.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-09-06
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Results First Submitted: 2018-10-30
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-11
• Last Update Submitted: 2019-03-11
• Results First Posted: 2019-06-10
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

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
(panto+amox+clar+metr)+(panto+amox)	(panto+amox+clar+metr)+(panto+amox)	a 7-day quadruple regimen with pantoprazole 40 mg twice 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 pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
pantoprazole+bismuth+tetra+metro	pantoprazole+bismuth+tetra+metro	pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

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	Evaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori)

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan