A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.

Phase

Condition

Heartburn (Pediatric)

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Treatment

Anaprazole + Rabeprazole placebo

Rabeprazole + Anaprazole placebo

Clinical Study ID

NCT07010107

3571-RE-3001

Ages 18-75
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 beforerandomization.

Exclusion

Exclusion Criteria:

Researchers believe that patients with uncontrolled primary diseases are notsuitable for clinical trials, particularly those with a history of severe conditionsaffecting the cardiovascular, nervous, respiratory, hepatic, renal, or othersystems.
Patients with concomitant diseases that may affect the esophagus or esophagealmotility and, could potentially influence the efficacy evaluation.
Patients with a history of prior surgical procedures that could potentially impactesophageal function, or surgeries.
Patients confirmed to have active peptic ulcers or active upper/lowergastrointestinal 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, inflammatorybowel disease, or other gastrointestinal functional disorders.
Patients with a history of malignant tumor or having received treatment formalignant tumor within 5 years prior to randomization.
Patients with a history of mental illness or a history of drug or alcohol abusewithin 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 oresophagus.
Patients with abnormal liver function: AST and/or ALT levels ≥2.0×ULN, and/or totalbilirubin (TBIL) levels ≥1.5×ULN.
Patients with abnormal renal function: Serum creatinine levels ≥1.5×ULN, blood ureaor blood urea nitrogen levels ≥1.5×ULN.
Patients with clinically significant ECG abnormalities, including QTc intervalprolongation (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 orRabeprazole.
Patients who had used proton pump inhibitors at therapeutic doses within 14 daysprior to randomization.
Patients who had used therapeutic doses of other drugs for treating acid refluxwithin 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 withdrawalduring the study.
Pregnant or lactating women, as well as patients planning to conceive within 30 daysbefore randomization and up to 6 months following the trial completion.
Patients who had participated in other drug clinical trials within 3 months prior torandomization.
Patients with other conditions deemed by the researchers as unsuitable forparticipation in this clinical trial.

Study Design