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RECRUITING
NCT07010107
PHASE3

A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.

Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This Phase III clinical trial is designed to assess the efficacy and safety of Anaprazole 60 mg once daily (QD) administered over a period of up to 8 weeks, compared with Rabeprazole 20 mg QD, in patients with reflux esophagitis.

Official title: Efficacy and Safety of Anaprazole in the Treatment of Reflux Esophagitis: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Positive-Controlled Phase III Clinical Trial.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2025-07-30

Completion Date

2026-08

Last Updated

2025-09-29

Healthy Volunteers

No

Interventions

DRUG

Anaprazole + Rabeprazole placebo

Anaprazole 3 tablets (20 mg/tablet) + Rabeprazole placebo 1 tablet (0.16 g/tablet), administered orally 30-60 minutes before breakfast once daily for up to 8 weeks. After 4 weeks of continuous treatment, if endoscopic evaluation confirms the cure of reflux esophagitis, treatment may be discontinued.

DRUG

Rabeprazole + Anaprazole placebo

Rabeprazole 1 tablet (20 mg/tablet) + Anaprazole placebo 3 tablets (0.2 g/tablet), orally administered 30-60 minutes before breakfast once daily for up to 8 weeks. After 4 weeks of continuous treatment, if endoscopic evaluation confirms the cure of reflux esophagitis, treatment may be discontinued.

Locations (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China