Esomeprazole
Drug20mg bid
NCT Number: NCT05250050
This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the Helicobacter pylori treatment.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Huashan Hospital, Fudan University, Shanghai, Shanghai Municipality, China
This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the treatment of Helicobacter pylori in patients with chronic gastritis. This study will compare the efficacy of individualized and empirical drug sensitivity regimens, and conduct cost-effectiveness analysis to provide pharmacoeconomic guidance for clinical decision-making. At the same time, it will provide reference for the reasonable pricing of H.pylori drug sensitivity test and considering the health benefits brought by its inclusion in medical insurance.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
20mg bid
0.6g bid
0.4g qid
0.5g bid
0.5g qd
1g bid
0.5g qid
Time frame: 6 weeks
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).
Time frame: 6 weeks
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.
Time frame: 6 weeks
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.
Time frame: 2 weeks during therapy
The proportion of subjects with good adherence. Good adherence was defined as that subjects took more than 80% of the total medication.
Time frame: 2 weeks during therapy
Any possible adverse events during the 14-day treatment period were recorded.
Time frame: 6 weeks
Average medical cost related to therapy and followup in each group
Shanghai Zhongshan Hospital
Other
Clinical Efficacy and Health Economic Evaluation of Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment:Multicenter Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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