NCT01107938Unknown2 期
Efficacy and Safety of Ilaprazole for GERD: A Randomized,Double-Blind, Esomeprazole-Controlled,Phase2,Multicenter Trial in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 330
- 主要终点
- the proportion of patients with healed esophagitis at week 8
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)
15 mg ilaprazole
Experimental
干预措施: 15 mg ilaprazole (Drug)
40 mg esomeprazole
Active Comparator
干预措施: 40 mg esomeprazole (Drug)
结局指标
主要结局
the proportion of patients with healed esophagitis at week 8
时间窗: week 8
次要结局
- the proportion of patients healed at week 4(week 4)
- resolution of clinical symptoms(week 8)
研究者
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