A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.

NCT07010107 | Recruiting Phase 3

• 1 other identifier: 3571-RE-3001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reflux Esophagitis (RE)

Keywords

Anaprazole; Rabeprazole; Reflux Esophagitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 8 weeks

Secondary Outcomes (7)

• The endoscopic healing rate of reflux esophagitis

  Up to 4 weeks

• Changes in the severity and frequency of heartburn compared to the baseline

  Up to 8 weeks

• Changes in the severity and frequency of reflux compared to the baseline

  Up to 8 weeks

• The rate of improvement in the severity and frequency of heartburn

  Up to 8 weeks

• The rate of improvement in the severity and frequency of reflux

  Up to 8 weeks

Study Arms (2)

Anaprazole

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Interventions

Anaprazole + Rabeprazole placebo DRUG

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 + Anaprazole placebo DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients provided voluntary signed informed consent forms.
• Aged ≥18 years and ≤75 years old.
• Endoscopically diagnosed as reflux esophagitis (LA grade B-D) within 14 days before randomization.

You may not qualify if:

• 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.
• Patients with concomitant diseases that may affect the esophagus or esophageal motility and, could potentially influence the efficacy evaluation.
• Patients with a history of prior surgical procedures that could potentially impact esophageal function, or surgeries.
• Patients confirmed to have active peptic ulcers or active upper/lower gastrointestinal bleeding within the last 30 days via esophagogastroduodenoscopy (EGD).
• 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.
• Patients with a history of malignant tumor or having received treatment for malignant tumor within 5 years prior to randomization.
• Patients with a history of mental illness or a history of drug or alcohol abuse within 12 months prior to screening.
• Patients who tested positive for HIV, HBsAg, and/or HCV antibodies during screening.
• Patients with malignant tumors or a predisposition to malignancy in the stomach or esophagus.
• Patients with abnormal liver function: AST and/or ALT levels ≥2.0×ULN, and/or total bilirubin (TBIL) levels ≥1.5×ULN.
• Patients with abnormal renal function: Serum creatinine levels ≥1.5×ULN, blood urea or blood urea nitrogen levels ≥1.5×ULN.
• Patients with clinically significant ECG abnormalities, including QTc interval prolongation (QTcF ≥450 ms for men and QTcF ≥470 ms for women).
• Patients with poorly controlled diabetes or hypertension.
• Patients who were unable to undergo esophagogastroduodenoscopy (EGD).
• Patients with a known allergy to the components or ingredients of Anaprazole or Rabeprazole.

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Esophagitis, Peptic

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Ya ping Luo

CONTACT

15367827140; luoyaping@xuanzhubio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: July 30, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

CN (1)