A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.

Официальное название

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.

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• The endoscopic healing rate of reflux esophagitis [Срок оценки: Up to 8 weeks]

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Changhai Hospital — Шанхай

Идентификаторы

NCT: NCT07010107 · 3571-RE-3001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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