A Phase 4 interventional study of Minocycline hydrochloride capsule and Clarithromycin in Helicobacter Pylori Eradication, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-01-13.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 4, Interventional, and Treatment
Although,bismuth-containing quadruple therapy has been highly recommended as first-line treatment regimen for H.pylori infection,it also has its problems and limitations in China.The primary resistance rates of metronidazole,clarithromycin and levofloxacin are all high in China.Besides that,tetracycline cannot be obtained and its complicated administration (four times daily) easily reduce patient compliance. In this study, we proposed to evaluate the eradication rate, safety, and compliance of a minocycline-based bismuth quadruple regimen.
A total of 339 H. pylori-infected, treatment-naive patients will be enrolled in this randomized controlled clinical trial. Patients will be randomly allocated into 3 groups: Esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days. Eradication rates will be assessed 4-12 weeks after treatment.
Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
Drug: Minocycline hydrochloride capsule · Drug: Amoxicillin · Drug: colloidal bismuth pectin · Drug: esomeprazole
Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.
Drug: Clarithromycin · Drug: Amoxicillin · Drug: colloidal bismuth pectin · Drug: esomeprazole
Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.
Drug: Minocycline hydrochloride capsule · Drug: Amoxicillin · Drug: colloidal bismuth pectin · Drug: esomeprazole
Antibiotic for H. pylori eradication
Also known as: Meiman
Antibiotic for H. pylori eradication
Also known as: Klacid
Antibiotic for H. pylori eradication
Gastric mucosal protective drug with anti-H. pylori effect
Proton pump inhibitor
Eradication rate
Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy
Time frame: 4-12 weeks after treatment
incidence of adverse effects
incidence of adverse effects of minocycline-containing bismuth quadruple therapy
Time frame: 3-7 days after treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University