A Study of Anaprazole Sodium Enteric-coated Tablets in the Treatment of Reflux Esophagitis

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.
• Treatments: Rabeprazole

Criteria

Inclusion Criteria:

1. Subjects clearly understand and voluntarily participate in this study, sign the informed consent form and voluntarily comply with the study procedures;

2. Age ≥ 18 years and ≤ 70 years, male or female;

3. Endoscopic diagnosis of reflux esophagitis (LA classification criteria grades A-D) within 7 days prior to randomization.

Exclusion Criteria:

Subjects who meet any of the following criteria will not be allowed to participate in this study:

Past medical history

1. Subjects whose primary diseases that are not suitable for participating in the clinical trial cannot be effectively controlled in the investigator 's opinion, such as patients with previous severe heart, brain, lung, liver, kidney and other systemic diseases;

2. Patients with previous concomitant diseases that may affect esophageal motility or motility, which may still affect the efficacy evaluation (e.g., eosinophilic esophagitis, esophageal varices, scleroderma, viral infection or fungal infection, esophageal stenosis, etc.) at the investigator 's discretion, or with a history of esophageal radiotherapy or esophageal cryotherapy;

3. History of previous surgical procedures that could affect the esophagus (eg, fundoplication and mechanical dilatation for esophageal strictures), or history of gastric or duodenal surgery, excluding endoscopic removal of benign polyps;

4. Subjects with active peptic ulcer, active upper/lower gastrointestinal bleeding confirmed by esophagogastroduodenoscopy (EGD) within 30 days prior to randomization;

5. Subjects with previous Zollinger-Ellison syndrome, achalasia, secondary esophageal motility disorder, irritable bowel syndrome, inflammatory bowel disease;

6. Prior malignancy or treatment for malignancy within 5 years prior to randomization (except cured cutaneous basal cell carcinoma or cervical carcinoma in situ);

7. Subjects who have a previous history of psychiatric disorders (except for patients with current psychiatric disorders who are stable and not under medication control as judged by the investigator), or a history of drug or alcohol abuse within 12 months prior to Screening.

General/Laboratory Tests

8. Abnormal liver function at screening: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥ 1.5 × ULN and/or total bilirubin (TBIL) ≥ 1.5 × ULN;

9. Abnormal renal function at screening: serum creatinine (Cr) ≥ 1.2 × ULN/blood urea nitrogen (BU)/blood urea nitrogen (BUN) ≥ 1.2 × ULN; Other conditions

10. Patients unable to undergo esophagogastroduodenoscopy (EGD);

11. Patients who are allergic to Annarazole Sodium or Rabeprazole Sodium and other drug ingredients or components that may be used in the study;

12. Use of therapeutic doses of drugs for gastroesophageal reflux disease such as proton pump inhibitors, potassium-competitive acid blockers, histamine H2 receptor antagonists, mucosal protective drugs, prokinetic drugs, anti-Helicobacter pylori drugs, and Chinese patent medicines for gastroesophageal reflux disease within 7 days before randomization;

13. Subjects who may affect the efficacy and safety evaluation due to alcohol, drug and drug withdrawal during the study;

14. Pregnant or lactating women, subjects with fertility plan from 30 days before randomization to half a year after the end of the trial;

15. Participation in another drug clinical trial (defined as receiving investigational product or placebo) within 3 months prior to randomization;

16. Other conditions that the investigator considers the subject unsuitable for this clinical trial.