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A Multicenter, Randomized, Double-blind, Double-dummy, Positive Drug Parallel Controlled Phase II Clinical Trial to Evaluate Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets in the Treatment of Reflux Esophagitis
A phase 2, randomized, double-blind, double-dummy, positive drug parallel controlled, multicenter trial to evaluate efficacy and safety of within 8 weeks (including 8 weeks) treatment of Anaprazole 40mg QD, 60mg QD compared with Rabeprazole 20mg QD in patients with reflux esophagitis.
Details
| Lead sponsor | Xuanzhu Biopharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 156 |
| Start date | 2022-12 |
| Completion | 2024-03 |
Conditions
- Reflux Esophagitis
- Gastroesophageal Reflux
- Esophagitis
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Gastrointestinal Diseases
Interventions
- Anaprazole sodium 40 mg
- Anaprazole sodium 60 mg
- Rabeprazole sodium 20 mg
Primary outcomes
- The endoscopic healing rate of reflux esophagitis within 8 weeks (including 8 weeks) — Treatment of 4 weeks or 8 weeks
The endoscopic ulcer healing rate is defined as the percentage of patients with reflux esophagitis healed evaluated by blinded independency central reading. Reflux esophagitis is evaluated by endoscopy as per LA Classification.
Countries
China