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Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy

NCT ID: NCT02646332

Last Updated: 2020-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Helicobacter Pylori Infection

Keywords

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Helicobacter pylori Eradication rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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(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

Group Type EXPERIMENTAL

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

Intervention Type 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+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

Group Type ACTIVE_COMPARATOR

dexlan+clarith+amox+metro

Intervention Type DRUG

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

Interventions

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(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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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dexlansoprazole MR 60 mg amoxicillin 1 g clarithromycin 500 mg metronidazole 250 mg dexlansoprazole MR 60 mg clarithromycin 500 mg amoxicillin 1 g metronidazole 250 mg

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Ping-I (William) Hsu, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ping-I Hsu, Bachelor

Role: STUDY_CHAIR

Kaohsiung Veterans General Hospital.

Locations

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Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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VGHKS15-CT7-15

Identifier Type: -

Identifier Source: org_study_id