A Clinical Trial of Anaprazole for Treating Reflux Esophagitis. (NCT07010107) | Clinical Trial Compass
RecruitingPhase 3
A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.
China500 participantsStarted 2025-07-30
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The patients provided voluntary signed informed consent forms.
✓. Aged ≥18 years and ≤75 years old.
✓. Endoscopically diagnosed as reflux esophagitis (LA grade B-D) within 14 days before randomization.
Exclusion criteria
✕. 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.
✕. Patients with concomitant diseases that may affect the esophagus or esophageal motility and, could potentially influence the efficacy evaluation.
✕. Patients with a history of prior surgical procedures that could potentially impact esophageal function, or surgeries.
✕. Patients confirmed to have active peptic ulcers or active upper/lower gastrointestinal bleeding within the last 30 days via esophagogastroduodenoscopy (EGD).
✕. 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.
✕. Patients with a history of malignant tumor or having received treatment for malignant tumor within 5 years prior to randomization.
✕. Patients with a history of mental illness or a history of drug or alcohol abuse within 12 months prior to screening.