High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment

NCT ID: NCT04024527

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-25

Study Completion Date

2021-05-24

Brief Summary

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Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.

Detailed Description

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Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dual therapy

Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

Proton pump inhibitor

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

Metronidazole plus dual therapy

Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

Proton pump inhibitor

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

Metronidazole

Intervention Type DRUG

Antibiotic for H. pylori eradication

Interventions

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Esomeprazole

Proton pump inhibitor

Intervention Type DRUG

Amoxicillin

Antibiotic for H. pylori eradication

Intervention Type DRUG

Metronidazole

Antibiotic for H. pylori eradication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants with non-ulcer functional dyspepsia or peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment failure

Exclusion Criteria

* Less than 18 years old or older than 80 years
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Administration of antibiotics, bismuth,antisecretory drugs in 8 weeks prior to inclusion
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hong Lu, MD

Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Lu, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

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Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Ding ZH, Huang Y, Chen JN, Luo LS, Zhang W, Liang X, Lu H. A randomized superiority clinical trial: metronidazole improved the efficacy of high-dose dual therapy in Helicobacter pylori rescue treatment. J Antimicrob Chemother. 2023 Mar 2;78(3):828-831. doi: 10.1093/jac/dkad020.

Reference Type DERIVED
PMID: 36719104 (View on PubMed)

Other Identifiers

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rjyy20190715

Identifier Type: -

Identifier Source: org_study_id

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