Anaprazole versus rabeprazole for 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.

This trial will try 60 mg anaprazole once daily versus 20 mg rabeprazole once daily for up to 8 weeks in adults with LA grade B–D reflux esophagitis.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07010107 on ClinicalTrials.gov

What this trial studies

In this Phase III trial, adults aged 18–75 with endoscopically confirmed LA grade B–D reflux esophagitis are randomized to receive either anaprazole 60 mg once daily plus rabeprazole placebo or rabeprazole 20 mg once daily plus anaprazole placebo for up to 8 weeks. Endoscopy is performed at baseline and at follow-up visits to document mucosal healing, while adverse events and laboratory tests are monitored to characterize safety. Matching placebos are used to maintain blinding between treatment groups. The sponsor is Xuanzhu Biopharmaceutical and the study is conducted at Shanghai Changhai Hospital.

Who should consider this trial

Good fit: Adults 18–75 who give informed consent and have endoscopic confirmation of LA grade B–D reflux esophagitis within 14 days of randomization, without uncontrolled major comorbidities, are the intended participants.

Not a fit: Patients with prior esophageal surgery, esophageal motility disorders, active peptic ulcers or recent GI bleeding, Zollinger–Ellison syndrome, achalasia, uncontrolled major diseases, or those outside the 18–75 age range are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, anaprazole could provide an alternative proton pump inhibitor that heals the esophagus as well as or better than rabeprazole with acceptable safety.

How similar studies have performed: Established proton pump inhibitors like rabeprazole are proven for reflux esophagitis, and anaprazole showed promise in earlier-phase work, but comparative phase III evidence is still limited.

Eligibility criteria

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.
11. Patients with abnormal renal function: Serum creatinine levels ≥1.5×ULN, blood urea or blood urea nitrogen levels ≥1.5×ULN.
12. Patients with clinically significant ECG abnormalities, including QTc interval prolongation (QTcF ≥450 ms for men and QTcF ≥470 ms for women).
13. Patients with poorly controlled diabetes or hypertension.
14. Patients who were unable to undergo esophagogastroduodenoscopy (EGD).
15. Patients with a known allergy to the components or ingredients of Anaprazole or Rabeprazole.
16. Patients who had used proton pump inhibitors at therapeutic doses within 14 days prior to randomization.
17. Patients who had used therapeutic doses of other drugs for treating acid reflux within 7 days prior to randomization.
18. Patients required to continue receiving non-steroidal anti-inflammatory drugs (NSAIDs), systemic glucocorticoids, or clopidogrel during the trial period.
19. Patients whose assessment may be affected by alcohol, drug, or medication withdrawal during the study.
20. Pregnant or lactating women, as well as patients planning to conceive within 30 days before randomization and up to 6 months following the trial completion.
21. Patients who had participated in other drug clinical trials within 3 months prior to randomization.
22. Patients with other conditions deemed by the researchers as unsuitable for participation in this clinical trial.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Changhai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ya ping Luo

Conditions Reflux Esophagitis; Anaprazole; Rabeprazole