A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.

Official title

Efficacy and Safety of Anaprazole in the Treatment of Reflux Esophagitis: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Positive-Controlled Phase III Clinical Trial.

Overview

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.

Interventions

• Drug Anaprazole + Rabeprazole placebo
  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 Rabeprazole + Anaprazole placebo
  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.

Primary outcome measures

• The endoscopic healing rate of reflux esophagitis [Time frame: Up to 8 weeks]

Secondary outcome measures (7)

• The endoscopic healing rate of reflux esophagitis [Time frame: Up to 4 weeks]
• Changes in the severity and frequency of heartburn compared to the baseline [Time frame: Up to 8 weeks]
• Changes in the severity and frequency of reflux compared to the baseline [Time frame: Up to 8 weeks]
• The rate of improvement in the severity and frequency of heartburn [Time frame: Up to 8 weeks]
• The rate of improvement in the severity and frequency of reflux [Time frame: Up to 8 weeks]
• Change from baseline in the Gastroesophageal Reflux Disease Health-Related Quality of Life Questionnaire (GERD-HRQL) score [Time frame: Up to 8 weeks]
• Adverse events [Time frame: Up to 8 weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Patients who had used proton pump inhibitors at therapeutic doses within 14 days prior to randomization.
• Patients who had used therapeutic doses of other drugs for treating acid reflux within 7 days prior to randomization.
• Patients required to continue receiving non-steroidal anti-inflammatory drugs (NSAIDs), systemic glucocorticoids, or clopidogrel during the trial period.
• Patients whose assessment may be affected by alcohol, drug, or medication withdrawal during the study.
• Pregnant or lactating women, as well as patients planning to conceive within 30 days before randomization and up to 6 months following the trial completion.
• Patients who had participated in other drug clinical trials within 3 months prior to randomization.
• Patients with other conditions deemed by the researchers as unsuitable for participation in this clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Changhai Hospital — Shanghai

Identifiers

NCT: NCT07010107 · 3571-RE-3001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗