Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment
NCT ID: NCT02732249
Last Updated: 2018-06-26
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
66 participants
INTERVENTIONAL
2016-04-01
2017-09-30
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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Triple regimen group
Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days
Esomeprazole
Given 30 min before morning and evening meals
Clarithromycin
Given 30 min after morning and evening meals
Metronidazole
Given 30 min after meals or at bedtime
Low metronidazole group
Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days
Esomeprazole
Given 30 min before morning and evening meals
Bismuth Potassium Citrate
Given 30 min before morning and evening meals
Clarithromycin
Given 30 min after morning and evening meals
Metronidazole
Given 30 min after meals or at bedtime
High metronidazole group
Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days
Esomeprazole
Given 30 min before morning and evening meals
Bismuth Potassium Citrate
Given 30 min before morning and evening meals
Clarithromycin
Given 30 min after morning and evening meals
Metronidazole
Given 30 min after meals or at bedtime
Interventions
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Esomeprazole
Given 30 min before morning and evening meals
Bismuth Potassium Citrate
Given 30 min before morning and evening meals
Clarithromycin
Given 30 min after morning and evening meals
Metronidazole
Given 30 min after meals or at bedtime
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
Exclusion Criteria
* Less than 18 years old
* With history of H. pylori infection treatment
* 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
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
Principal Investigators
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Hong lu, MD
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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Other Identifiers
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rjkls2016068
Identifier Type: -
Identifier Source: org_study_id
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