A Phase 3 interventional study of Anaprazole + Rabeprazole placebo and Rabeprazole + Anaprazole placebo in Reflux Esophagitis (RE), sponsored by Xuanzhu Biopharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Xuanzhu Biopharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
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: Anaprazole + Rabeprazole 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.
Drug: Rabeprazole + Anaprazole 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.
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.
The endoscopic healing rate of reflux esophagitis
The endoscopic healing rate of reflux esophagitis is defined as the proportion of patients with reflux esophagitis who achieve complete mucosal healing. Complete healing is determined by the absence of mucosal breaks upon endoscopic evaluation post-treatment, and the lesion is classified as normal according to the LA classification.
Time frame: Up to 8 weeks
The endoscopic healing rate of reflux esophagitis
The endoscopic healing rate of reflux esophagitis is defined as the proportion of patients with reflux esophagitis who achieve complete mucosal healing. Complete healing is determined by the absence of mucosal breaks upon endoscopic evaluation post-treatment, and the lesion is classified as normal according to the LA classification.
Time frame: Up to 4 weeks
Changes in the severity and frequency of heartburn compared to the baseline
The analysis was performed using a symptom assessment questionnaire. On Day 1 of treatment, participants reported their symptoms experienced during the 7 days prior to randomization. On Days 29 and 57 of treatment, and visits for early trial withdrawal, symptom data were recorded based on the completion status of the 7-day diary cards filled out by participants immediately preceding each visit. The severity of heartburn was evaluated using a 4-point scale, while the frequency of occurrence of heartburn was assessed using a 5-point scale.
Time frame: Up to 8 weeks
Changes in the severity and frequency of reflux compared to the baseline
The analysis was performed using a symptom assessment questionnaire. On Day 1 of treatment, participants reported their symptoms experienced during the 7 days prior to randomization. On Days 29 and 57 of treatment, and visits for early trial withdrawal, symptom data were recorded based on the completion status of the 7-day diary cards filled out by participants immediately preceding each visit. The severity of reflux was evaluated using a 4-point scale, while the frequency of occurrence of reflux was assessed using a 5-point scale.
Time frame: Up to 8 weeks
The rate of improvement in the severity and frequency of heartburn
Standard for evaluating improvement in severity of individual symptoms: Calculate the average severity score for the 7 days prior to the 4-week and 8-week visits separately. The average score = total of individual scores recorded within 7 days / number of recording days. * Complete remission: The average score drops to 0 points * Improvement: The average score decreases by at least 1 point * No effect: The average score remains unchanged or increases. Standard for scoring the frequency of individual symptoms: 0 points: 0 days; 1 point: 1 day; 2 points: 2-3 days; 3 points: 4-5 days; 4 points: 6-7 days; The improvement rate of individual symptom severity/frequency = (Number of improved cases / Total number of cases) × 100%.
Time frame: Up to 8 weeks
The rate of improvement in the severity and frequency of reflux
Standard for evaluating improvement in severity of individual symptoms: Calculate the average severity score for the 7 days prior to the 4-week and 8-week visits separately. The average score = total of individual scores recorded within 7 days / number of recording days. * Complete remission: The average score drops to 0 points * Improvement: The average score decreases by at least 1 point * No effect: The average score remains unchanged or increases. Standard for scoring the frequency of individual symptoms: 0 points: 0 days; 1 point: 1 day; 2 points: 2-3 days; 3 points: 4-5 days; 4 points: 6-7 days; The improvement rate of individual symptom severity/frequency = (Number of improved cases / Total number of cases) × 100%.
Time frame: Up to 8 weeks
Change from baseline in the Gastroesophageal Reflux Disease Health-Related Quality of Life Questionnaire (GERD-HRQL) score
GERD related quality of life (QoL) is assessed with the "gastroesophageal reflux disease - health related quality of life" (GERD-HRQL) questionnaire. QoL is measured at baseline, Days 29 and 57 of treatment, and visits for early trial withdrawal. The scale contains 10 questions and a symptom control satisfaction survey, which focuses on heartburn, acid reflux, swallowing function, and drug efficacy. Each question is scored according to a 6-point scoring criterion (0 indicates no symptoms, 5 indicates intolerable symptoms, and affects daily activities), and the total score is the sum of the scores of each item (0-50 points in total), with higher scores indicating worse quality of life. Satisfaction is divided into three levels: dissatisfaction, moderate, and satisfaction. Change in GERD-HRQL score = total GERD-HRQL score after treatment - total GERD-HRQL score before treatment.
Time frame: Up to 8 weeks
Adverse events
The treatment-emergent adverse events are evaluated by CTCAE v5.0
Time frame: Up to 8 weeks
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Xuanzhu Biopharmaceutical Co., Ltd.