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ACTIVE NOT RECRUITING
NCT06523764
PHASE4

Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment

Sponsor: Xijing Hospital of Digestive Diseases

View on ClinicalTrials.gov

Summary

The purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Official title: Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment : A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2024-11-11

Completion Date

2025-10-01

Last Updated

2025-07-03

Healthy Volunteers

No

Interventions

DRUG

tegoprazan

tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days

DRUG

Minocycline

tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days

DRUG

bismuth potassium citrate

bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days

DRUG

Esomeprazole 40mg

bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days

DRUG

Amoxicillin

bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days

DRUG

clarithromycin

bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days

Locations (1)

Xijing hospital

Xi'an, Shaanxi, China