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

Primary Purpose

Reflux Esophagitis, Gastroesophageal Reflux, Esophagitis

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anaprazole sodium 40 mg
Anaprazole sodium 60 mg
Rabeprazole sodium 20 mg
Sponsored by
Xuanzhu Biopharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reflux Esophagitis focused on measuring Anti-Ulcer Agents, Gastrointestinal Agents, Proton Pump Inhibitors, Enzyme Inhibitors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; Subjects who may affect the efficacy and safety evaluation due to alcohol, drug and drug withdrawal during the study; Pregnant or lactating women, subjects with fertility plan from 30 days before randomization to half a year after the end of the trial; Participation in another drug clinical trial (defined as receiving investigational product or placebo) within 3 months prior to randomization; Other conditions that the investigator considers the subject unsuitable for this clinical trial.

Sites / Locations

  • Shanghai Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Anaprazole sodium 40 mg QD

Anaprazole sodium 60 mg QD

Rabeprazole sodium 20 mg QD

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The rate of improvement in each individual symptom (daytime reflux)
The assessment of improvement of daytime reflux is evaluated in terms of severity and frequency. Mean severity scores are calculated for the first 7 days of the 4-week and 8-week visits, respectively. Mean score = sum of individual scores recorded over 7 days/number of days recorded. Complete response: mean score/score reduced to 0. Improvement:mean score/score reduced to 1. Ineffective: no change or increase in mean score/score. Complete response rate = number of complete response cases/total number of cases × 100%. Improvement rate = number of improved cases/total number of cases × 100%.
The rate of improvement in each individual symptom (daytime heartburn)
The assessment of improvement of daytime heartburn is evaluated in terms of severity and frequency. Mean severity scores are calculated for the first 7 days of the 4-week and 8-week visits, respectively. Mean score = sum of individual scores recorded over 7 days/number of days recorded. Complete response: mean score/score reduced to 0. Improvement:mean score/score reduced to 1. Ineffective: no change or increase in mean score/score. Complete response rate = number of complete response cases/total number of cases × 100%. Improvement rate = number of improved cases/total number of cases × 100%.
The rate of improvement in each individual symptom (nighttime reflux)
The assessment of improvement of nighttime reflux is evaluated in terms of severity and frequency. Mean severity scores are calculated for the first 7 days of the 4-week and 8-week visits, respectively. Mean score = sum of individual scores recorded over 7 days/number of days recorded. Complete response: mean score/score reduced to 0. Improvement:mean score/score reduced to 1. Ineffective: no change or increase in mean score/score. Complete response rate = number of complete response cases/total number of cases × 100%. Improvement rate = number of improved cases/total number of cases × 100%.
The rate of improvement in each individual symptom (nighttime heartburn)
The assessment of improvement of nighttime heartburn is evaluated in terms of severity and frequency of each of the four individual symptoms. Mean severity scores are calculated for the first 7 days of the 4-week and 8-week visits, respectively. Mean score = sum of individual scores recorded over 7 days/number of days recorded. Complete response: mean score/score reduced to 0. Improvement:mean score/score reduced to 1. Ineffective: no change or increase in mean score/score. Complete response rate = number of complete response cases/total number of cases × 100%. Improvement rate = number of improved cases/total number of cases × 100%.
Change From Baseline in gastroesophageal reflux disease health-related quality of life scale (GERD-HRQL) score
GERD related quality of life (QoL) is assessed with the "gastroesophageal reflux disease - health related quality of life" (GERD-HRQL) questionnaire. QoL is measured at baseline and at six months after treatment. The scale contains 10 questions and a symptom control satisfaction survey, which focuses on heartburn, acid reflux, swallowing function, and drug efficacy. Each question is scored according to a scoring criteria of 6 scores (0 indicates no symptoms, 5 indicates intolerable symptoms, and affects daily activities), and the total score is the sum of the scores of each item (0-50 points in total), with higher scores indicating worse quality of life. Satisfaction is divided into three levels: dissatisfaction, moderate, and satisfaction. Change in GERD-HRQL score = total GERD-HRQL score after treatment - total GERD-HRQL score before treatment.
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Full Information

First Posted
October 26, 2022
Last Updated
November 1, 2022
Sponsor
Xuanzhu Biopharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05604261
Brief Title
A Study of Anaprazole Sodium Enteric-coated Tablets in the Treatment of Reflux Esophagitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanzhu Biopharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a multicenter, randomized, double-blind, double-dummy, active drug-parallel-controlled, phase 2 clinical study to evaluate the efficacy and safety of Anaprazole Sodium 40 mg QD and 60 mg QD versus Rabeprazole Sodium 20 mg QD in the treatment of reflux esophagitis in Chinese subjects with reflux esophagitis. The target population for this study was subjects with endoscopically confirmed reflux esophagitis. All potential participants will provide informed consent, and those who provide informed consent will enter the Screening Period (Day -7 to Day -1) and be assessed for screening eligibility according to the inclusion and exclusion criteria. The study is expected to enroll approximately 156 subjects with reflux esophagitis (LA classification grades A-D) who meet enrollment criteria (and none of the exclusion criteria), and eligible subjects will be randomized into 3 groups (Anaprazole Sodium 40 mg QD, 60 mg QD, and Rabeprazole Sodium 20 mg QD) in a 1:1: 1 ratio according to a predefined randomization table, with 52 subjects in each group. All subjects take the corresponding study drug within 30-60 minutes before breakfast for 4 or 8 consecutive weeks (subjects were followed up at Week 4 of treatment, and if the subject'endoscopy indicated that the reflux esophagitis was healed, the healed subject ended study treatment and entered safety follow-up. Subjects who were not cured were to continue treatment until 8 weeks if endoscopy at 4 weeks of treatment indicated that reflux esophagitis was not cured.). All subjects complete treatment at 4 or 8 weeks of treatment and were followed for safety. At the end of the study, statistical analysis will be performed on the efficacy and safety indicators of the study drug to compare the efficacy and safety of Anaprazole sodium and rabeprazole sodium in the treatment of reflux esophagitis. Participants will primarily be assessed for the cure rate of reflux esophagitis based on endoscopy of 3 groups. Participants' safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anaprazole sodium 40 mg QD
Arm Type
Experimental
Arm Title
Anaprazole sodium 60 mg QD
Arm Type
Experimental
Arm Title
Rabeprazole sodium 20 mg QD
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Anaprazole sodium 40 mg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Anaprazole sodium 60 mg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Rabeprazole sodium 20 mg
Intervention Description
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).
Primary Outcome Measure Information:
Title
The endoscopic healing rate of reflux esophagitis within 8 weeks (including 8 weeks)
Description
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.
Time Frame
Treatment of 4 weeks or 8 weeks
Secondary Outcome Measure Information:
Title
The rate of improvement in each individual symptom (daytime reflux)
Description
The assessment of improvement of daytime reflux is evaluated in terms of severity and frequency. Mean severity scores are calculated for the first 7 days of the 4-week and 8-week visits, respectively. Mean score = sum of individual scores recorded over 7 days/number of days recorded. Complete response: mean score/score reduced to 0. Improvement:mean score/score reduced to 1. Ineffective: no change or increase in mean score/score. Complete response rate = number of complete response cases/total number of cases × 100%. Improvement rate = number of improved cases/total number of cases × 100%.
Time Frame
Treatment of 4 weeks or 8 weeks
Title
The rate of improvement in each individual symptom (daytime heartburn)
Description
The assessment of improvement of daytime heartburn is evaluated in terms of severity and frequency. Mean severity scores are calculated for the first 7 days of the 4-week and 8-week visits, respectively. Mean score = sum of individual scores recorded over 7 days/number of days recorded. Complete response: mean score/score reduced to 0. Improvement:mean score/score reduced to 1. Ineffective: no change or increase in mean score/score. Complete response rate = number of complete response cases/total number of cases × 100%. Improvement rate = number of improved cases/total number of cases × 100%.
Time Frame
Treatment of 4 weeks or 8 weeks
Title
The rate of improvement in each individual symptom (nighttime reflux)
Description
The assessment of improvement of nighttime reflux is evaluated in terms of severity and frequency. Mean severity scores are calculated for the first 7 days of the 4-week and 8-week visits, respectively. Mean score = sum of individual scores recorded over 7 days/number of days recorded. Complete response: mean score/score reduced to 0. Improvement:mean score/score reduced to 1. Ineffective: no change or increase in mean score/score. Complete response rate = number of complete response cases/total number of cases × 100%. Improvement rate = number of improved cases/total number of cases × 100%.
Time Frame
Treatment of 4 weeks or 8 weeks
Title
The rate of improvement in each individual symptom (nighttime heartburn)
Description
The assessment of improvement of nighttime heartburn is evaluated in terms of severity and frequency of each of the four individual symptoms. Mean severity scores are calculated for the first 7 days of the 4-week and 8-week visits, respectively. Mean score = sum of individual scores recorded over 7 days/number of days recorded. Complete response: mean score/score reduced to 0. Improvement:mean score/score reduced to 1. Ineffective: no change or increase in mean score/score. Complete response rate = number of complete response cases/total number of cases × 100%. Improvement rate = number of improved cases/total number of cases × 100%.
Time Frame
Treatment of 4 weeks or 8 weeks
Title
Change From Baseline in gastroesophageal reflux disease health-related quality of life scale (GERD-HRQL) score
Description
GERD related quality of life (QoL) is assessed with the "gastroesophageal reflux disease - health related quality of life" (GERD-HRQL) questionnaire. QoL is measured at baseline and at six months after treatment. The scale contains 10 questions and a symptom control satisfaction survey, which focuses on heartburn, acid reflux, swallowing function, and drug efficacy. Each question is scored according to a scoring criteria of 6 scores (0 indicates no symptoms, 5 indicates intolerable symptoms, and affects daily activities), and the total score is the sum of the scores of each item (0-50 points in total), with higher scores indicating worse quality of life. Satisfaction is divided into three levels: dissatisfaction, moderate, and satisfaction. Change in GERD-HRQL score = total GERD-HRQL score after treatment - total GERD-HRQL score before treatment.
Time Frame
Treatment of 4 weeks or 8 weeks
Title
Adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; Subjects who may affect the efficacy and safety evaluation due to alcohol, drug and drug withdrawal during the study; Pregnant or lactating women, subjects with fertility plan from 30 days before randomization to half a year after the end of the trial; Participation in another drug clinical trial (defined as receiving investigational product or placebo) within 3 months prior to randomization; Other conditions that the investigator considers the subject unsuitable for this clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaping Luo
Phone
15367827140
Email
luoyaping@xuanzhubio.com
Facility Information:
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li
Phone
021-55621735
Email
zhaoshen-li@hotmail.com

12. IPD Sharing Statement

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

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