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

NCT05604261 | Unknown Phase 2

• 1 other identifier: 3571-RE-2001
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reflux Esophagitis; Gastroesophageal Reflux; Esophagitis; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases

Keywords

Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors

Outcome Measures

Primary Outcomes (1)

• The endoscopic healing rate of reflux esophagitis within 8 weeks (including 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.

  Treatment of 4 weeks or 8 weeks

Secondary Outcomes (6)

• The rate of improvement in each individual symptom (daytime reflux)

  Treatment of 4 weeks or 8 weeks

• The rate of improvement in each individual symptom (daytime heartburn)

  Treatment of 4 weeks or 8 weeks

• The rate of improvement in each individual symptom (nighttime reflux)

  Treatment of 4 weeks or 8 weeks

• The rate of improvement in each individual symptom (nighttime heartburn)

  Treatment of 4 weeks or 8 weeks

• Change From Baseline in gastroesophageal reflux disease health-related quality of life scale (GERD-HRQL) score

  Treatment of 4 weeks or 8 weeks

Study Arms (3)

Anaprazole sodium 40 mg QD

EXPERIMENTAL

Drug: Anaprazole sodium 40 mg

Anaprazole sodium 60 mg QD

EXPERIMENTAL

Drug: Anaprazole sodium 60 mg

Rabeprazole sodium 20 mg QD

ACTIVE COMPARATOR

Drug: Rabeprazole sodium 20 mg

Interventions

Anaprazole sodium 40 mg DRUG

Anaprazole sodium 2 tablets (20 mg/tablet) + Anaprazole sodium dummy tablets 1 tablet (20 mg/tablet) + Rabeprazole sodium dummy tablets 2 tablets (10 mg/tablet) orally once daily within 30-60 minutes before breakfast for 8 weeks (after 4 weeks of continuous treatment, if endoscopy shows reflux esophagitis is cured, treatment is discontinued, into the safety follow-up period).

Anaprazole sodium 40 mg QD

Anaprazole sodium 60 mg DRUG

Anaprazole sodium 3 tablets (20 mg/tablet) + Rabeprazole sodium dummy tablets 2 tablets (10 mg/tablet) orally once daily within 30-60 minutes before breakfast for 8 weeks (after 4 weeks of continuous treatment, if endoscopy shows reflux esophagitis is cured, treatment is discontinued, into the safety follow-up period).

Anaprazole sodium 60 mg QD

Rabeprazole sodium 20 mg DRUG

Anaprazole sodium dummy tablets 3 tablets (20 mg/tablet) + Rabeprazole sodium 2 tablets (10 mg/tablet) orally once daily within 30-60 minutes before breakfast for 8 weeks (after 4 weeks of continuous treatment, if endoscopy shows reflux esophagitis is cured, treatment is discontinued, into the safety follow-up period).

Rabeprazole sodium 20 mg QD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects clearly understand and voluntarily participate in this study, sign the informed consent form and voluntarily comply with the study procedures;
• Age ≥ 18 years and ≤ 70 years, male or female;
• Endoscopic diagnosis of reflux esophagitis (LA classification criteria grades A-D) within 7 days prior to randomization.

You may not qualify if:

• Subjects who meet any of the following criteria will not be allowed to participate in this study:
• Past medical history
• 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;
• 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;
• 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;
• Subjects with active peptic ulcer, active upper/lower gastrointestinal bleeding confirmed by esophagogastroduodenoscopy (EGD) within 30 days prior to randomization;
• Subjects with previous Zollinger-Ellison syndrome, achalasia, secondary esophageal motility disorder, irritable bowel syndrome, inflammatory bowel disease;
• Prior malignancy or treatment for malignancy within 5 years prior to randomization (except cured cutaneous basal cell carcinoma or cervical carcinoma in situ);
• 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
• Abnormal liver function at screening: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥ 1.5 × ULN and/or total bilirubin (TBIL) ≥ 1.5 × ULN;
• Abnormal renal function at screening: serum creatinine (Cr) ≥ 1.2 × ULN/blood urea nitrogen (BU)/blood urea nitrogen (BUN) ≥ 1.2 × ULN; Other conditions
• Patients unable to undergo esophagogastroduodenoscopy (EGD);
• Patients who are allergic to Annarazole Sodium or Rabeprazole Sodium and other drug ingredients or components that may be used in the study;
• 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;

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Esophagitis, Peptic; Gastroesophageal Reflux; Esophagitis; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Pharyngeal Diseases; Otorhinolaryngologic 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

Yaping Luo

CONTACT

15367827140; luoyaping@xuanzhubio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: October 26, 2022
• First Posted: November 3, 2022
• Study Start: December 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: March 1, 2024
• Last Updated: November 3, 2022

Record last verified: 2022-10

Locations

CN (1)