RecruitingPhase 3NCT07010107

A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.

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.


Sponsor

Xuanzhu Biopharmaceutical Co., Ltd.

Enrollment

500 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 clinical trial is comparing a new acid-suppressing drug, Anaprazole 60 mg, against the established medication Rabeprazole 20 mg for treating reflux esophagitis — inflammation of the esophagus caused by acid reflux, confirmed by endoscopy. The goal is to determine whether Anaprazole heals the esophagus as effectively and safely as Rabeprazole over up to 8 weeks. Adults aged 18 to 75 who have been diagnosed with grade B, C, or D reflux esophagitis by endoscopy within the past 14 days may be eligible, unless they have serious heart, liver, or kidney disease, active ulcers, or other conditions affecting the esophagus. Participation involves taking the assigned medication daily for up to 8 weeks and attending clinic visits for monitoring. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnaprazole + 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.

DRUGRabeprazole + 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

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NCT07010107


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