A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.
NCT ID: NCT07010107
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2025-07-30
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anaprazole
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.
Anaprazole + Rabeprazole 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
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.
Rabeprazole + Anaprazole 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.
Interventions
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Anaprazole + Rabeprazole 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 + Anaprazole 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Xuanzhu Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3571-RE-3001
Identifier Type: -
Identifier Source: org_study_id
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