Actively Recruiting
A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.
Led by Xuanzhu Biopharmaceutical Co., Ltd. · Updated on 2025-09-29
500
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have voluntarily signed informed consent forms
- Aged 18 years or older and up to 75 years old
- Diagnosed with reflux esophagitis (LA grade B-D) by endoscopy within 14 days before randomization
You will not qualify if you...
- Patients with uncontrolled major diseases affecting cardiovascular, nervous, respiratory, hepatic, renal, or other systems
- Patients with diseases affecting the esophagus or esophageal movement that might affect treatment evaluation
- History of surgeries impacting esophageal function
- Active peptic ulcers or active gastrointestinal bleeding within the past 30 days
- History of Zollinger-Ellison syndrome, achalasia, secondary esophageal motility disorders, irritable bowel syndrome, inflammatory bowel disease, or other gastrointestinal functional disorders
- History of malignant tumors or cancer treatment within the past 5 years
- History of mental illness or drug/alcohol abuse within 12 months prior to screening
- Positive test for HIV, hepatitis B surface antigen, or hepatitis C antibodies
- Presence of malignant tumors or risk of malignancy in stomach or esophagus
- Abnormal liver function with AST/ALT ≥2.0 times upper limit of normal or total bilirubin ≥1.5 times upper limit
- Abnormal kidney function with serum creatinine or blood urea nitrogen ≥1.5 times upper limit
- Significant ECG abnormalities including prolonged QTc interval
- Poorly controlled diabetes or high blood pressure
- Unable to undergo esophagogastroduodenoscopy
- Allergy to Anaprazole or Rabeprazole components
- Use of proton pump inhibitors at treatment doses within 14 days before randomization
- Use of other acid reflux treatment drugs at therapeutic doses within 7 days prior to randomization
- Requirement to continue NSAIDs, systemic glucocorticoids, or clopidogrel during the study
- Conditions affecting assessment due to alcohol, drug, or medication withdrawal during the study
- Pregnant or breastfeeding women or planning pregnancy within 30 days before or 6 months after the study
- Participation in other drug clinical trials within 3 months before randomization
- Any other conditions deemed unsuitable by the researchers for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
Y
Ya ping Luo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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