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.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The endoscopic healing rate of reflux esophagitis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Anaprazole
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.
干预措施: Anaprazole + Rabeprazole placebo (Drug)
Rabeprazole
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.
干预措施: Rabeprazole + Anaprazole placebo (Drug)
结局指标
主要结局
The endoscopic healing rate of reflux esophagitis
时间窗: Up to 8 weeks
The endoscopic healing rate of reflux esophagitis is defined as the proportion of patients with reflux esophagitis who achieve complete mucosal healing. Complete healing is determined by the absence of mucosal breaks upon endoscopic evaluation post-treatment, and the lesion is classified as normal according to the LA classification.
次要结局
- The endoscopic healing rate of reflux esophagitis(Up to 4 weeks)
- Changes in the severity and frequency of heartburn compared to the baseline(Up to 8 weeks)
- Changes in the severity and frequency of reflux compared to the baseline(Up to 8 weeks)
- The rate of improvement in the severity and frequency of heartburn(Up to 8 weeks)
- The rate of improvement in the severity and frequency of reflux(Up to 8 weeks)
- Change from baseline in the Gastroesophageal Reflux Disease Health-Related Quality of Life Questionnaire (GERD-HRQL) score(Up to 8 weeks)
- Adverse events(Up to 8 weeks)