High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment
NCT ID: NCT04024527
Last Updated: 2021-09-28
Study Results
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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COMPLETED
PHASE4
306 participants
INTERVENTIONAL
2019-07-25
2021-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dual therapy
Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days
Esomeprazole
Proton pump inhibitor
Amoxicillin
Antibiotic for H. pylori eradication
Metronidazole plus dual therapy
Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Esomeprazole
Proton pump inhibitor
Amoxicillin
Antibiotic for H. pylori eradication
Metronidazole
Antibiotic for H. pylori eradication
Interventions
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Esomeprazole
Proton pump inhibitor
Amoxicillin
Antibiotic for H. pylori eradication
Metronidazole
Antibiotic for H. pylori eradication
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Hong Lu, MD
Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
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
Countries
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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.
Other Identifiers
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rjyy20190715
Identifier Type: -
Identifier Source: org_study_id
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