A Phase 4 interventional study of Esomeprazole and Amoxicillin in Helicobacter Pylori Infection, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-11-05.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment
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Dual therapy for Helicobacter Pylori including a proton pump inhibitor (PPI) and amoxicillin. Amoxicillin has low resistance rate as well as low percentage of side effects. No trial has examined the the efficacy of high dose of dual therapy plus bismuth for H. pylori treatment.This study is designed to evaluate the efficacy and safety of the addition of bismuth to high dose of dual therapy for H. pylori eradication.
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Bismuth Potassium Citrate 600mg bid for 14 days.
Drug: Esomeprazole · Drug: Amoxicillin · Drug: Bismuth Potassium Citrate
Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days.
Drug: Esomeprazole · Drug: Amoxicillin
Proton pump inhibitor
Antibiotic for H. pylori eradication
Gastric mucosal protective drug with anti-H. pylori effect
Helicobacter pylori eradication rate
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
Time frame: Six weeks after completion of therapy
Rate of adverse effects
The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities).
Time frame: Within 7 days after completion of therapy.
Compliance rate
Compliance was defined as poor when they had taken less than 80% of the total medication.
Time frame: Within 7 days after completion of therapy.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Nov 2018, 9 months.
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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bismuth
Shanghai Jiao Tong University School of Medicine →