NCT02860624已完成3 期
Efficacy and Safety of Ilaprazole for GERD: A Randomized, Double-Blind, Esomeprazole-Controlled, Phase 3, Multicenter Trial in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 550
- 主要终点
- Changes in stage of the ulcer assessed by endoscopic(week 8) changes relative to baseline (week 0) levels.
研究概览
简要总结
This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting patients will be eligible for enrollment if they:
- •are 18-70 years of age,
- •have at least one of the two symptoms, heartburn and reflux,
- •have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test.
排除标准
- •Patients will be ineligible if they:
- •have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach
- •have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
- •have severe complications, severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
- •have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,
- •participated in a clinical trial with an investigational drug or device within the past three months,
- •have hypersensitivity or idiosyncratic reaction to ilaprazole, esomeprazole or any other benzimidazole,
- •have alcoholic intemperance, drug addiction or any other improper habits.
研究组 & 干预措施
10 mg ilaprazole
Experimental
干预措施: 10 mg ilaprazole (Drug)
40 mg esomeprazole
Active Comparator
干预措施: 40mg esomeprazole (Drug)
结局指标
主要结局
Changes in stage of the ulcer assessed by endoscopic(week 8) changes relative to baseline (week 0) levels.
时间窗: week 8
次要结局
未报告次要终点
研究者
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