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NOT YET RECRUITING
NCT07606833
PHASE3

The Clinical Trail to Evaluate the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Combined With Bismuth-containing Quadruple Therapy in Eradicating Helicobacter Pylori

Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double blind, double-simulated, parallel control of positive drug phase III clinical study to evaluate the efficacy and safety of Anaprazole versus Esomeprazole-containing Bismuth quadruple therapy for eradication of Helicobacter pylori in China.

Official title: A Multicenter, Randomized, Double Blind, Double-simulated, Parallel Control of Positive Drug Phase III Clinical Study Evaluating the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Containing Bismuth in Quadruple Therapy for the Eradication of Helicobacter Pylori

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

556

Start Date

2026-06-10

Completion Date

2027-03-18

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

DRUG

Anaprazole Sodium enteric-coated tablet

Anaprazole sodium enteric-coated tablets 20mg + Esomeprazole magnesium enteric-coated tablets placebo 1 tablet +Bismuth potassium citrate capsules 240mg + Amoxicillin capsules 1000mg + Clarithromycin tablets 500mg,BID,oral,twice daily for 14 days

DRUG

Esomeprazole magnesium enteric-coated tablets

Anaprazole sodium enteric-coated tablets placebo 1 tablet + Esomeprazole magnesium enteric-coated tablets20mg +Bismuth potassium citrate capsules 240mg + Amoxicillin capsules 1000mg + Clarithromycin tablets 500mg,BID,oral,twice daily for 14 days

Locations (1)

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China