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A Clinical Trial of Anaprazole for Treating Reflux Esophagitis. | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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.

NCT07010107•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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patients provided voluntary signed informed consent forms.
•2. Aged ≥18 years and ≤75 years old.
•3. Endoscopically diagnosed as reflux esophagitis (LA grade B-D) within 14 days before randomization.

Exclusion Criteria

•1. Researchers believe that patients with uncontrolled primary diseases are not suitable for clinical trials, particularly those with a history of severe conditions affecting the cardiovascular, nervous, respiratory, hepatic, renal, or other systems.
•2. Patients with concomitant diseases that may affect the esophagus or esophageal motility and, could potentially influence the efficacy evaluation.
•3. Patients with a history of prior surgical procedures that could potentially impact esophageal function, or surgeries.
•4. Patients confirmed to have active peptic ulcers or active upper/lower gastrointestinal bleeding within the last 30 days via esophagogastroduodenoscopy (EGD).
•5. Patients with a history of Zollinger-Ellison syndrome, achalasia of the cardia, secondary esophageal motility disorders, irritable bowel syndrome, inflammatory bowel disease, or other gastrointestinal functional disorders.
•6. Patients with a history of malignant tumor or having received treatment for malignant tumor within 5 years prior to randomization.
•7. Patients with a history of mental illness or a history of drug or alcohol abuse within 12 months prior to screening.
•8. Patients who tested positive for HIV, HBsAg, and/or HCV antibodies during screening.
•9. Patients with malignant tumors or a predisposition to malignancy in the stomach or esophagus.
•10. Patients with abnormal liver function: AST and/or ALT levels ≥2.0×ULN, and/or total bilirubin (TBIL) levels ≥1.5×ULN.
+12 more criteria

Locations (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

July 30, 2025

Primary Completion Date

April 1, 2026

Completion Date

August 1, 2026

Last Updated

September 29, 2025

Enrollment

500

ESTIMATED participants

Conditions

Reflux Esophagitis (RE)

Interventions

Anaprazole + Rabeprazole placebo

DRUG

Rabeprazole + Anaprazole placebo

DRUG

Contacts

Ya ping Luo

CONTACT

15367827140 luoyaping@xuanzhubio.com

A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esophagitis

NCT06850480

Reflux Esophagitis (RE)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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