NCT01284647已完成4 期
A Prospective, Randomized, Double-blind, Double-dummy, Sucralfate Controlled, Multicenter Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 8
- 主要终点
- The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of teprenone on chronic non-atrophic erosive gastritis and its therapeutic mechanism
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •Have been diagnosed as chronic non-atrophic erosive gastritis by endoscopy within 1 weeks before enrollment, and the modified Lanza score ≥ 2
- •Have at least two symptoms in four major symptoms (epigastric pain, epigastric burning, early satiety, belching) and total symptom score ≥ 4 (Rome Ⅲ for Functional Gastrointestinal Disorders)
排除标准
- •Suspected upper gastrointestinal malignancy by endoscopy
- •Peptic ulcer and bleeding by endoscopy
- •Severe cardiac, hepatic or renal insufficiency
- •Severe neurological or psychological disease
- •Pregnant or lactating women
- •Have taken drugs which may affect evaluating the efficacy of study drug within two weeks before enrollment (includes but not limits to: Proton pump inhibitors such as omeprazole, rabeprazole, pantoprazole, lansoprazole, esomeprazole, H2 receptor antagonists such as cimetidine, ranitidine, famotidine, antacids such as calcium carbonate, gastric mucosal protectants such as colloidal bismuth potassium citrate and other bismuth products, sucralfate, aluminum phosphate, teprenone, gefarnate, aluminum magnesium carbonate, glutamine, rebamipide, ecabet, misoprostol, antibiotics such as amoxicillin, clarithromycin, tetracycline, ofloxacin, levofloxacin, furazolidone, metronidazole, tinidazole, Non-Steroid Anti-Inflammatory Drugs such as aspirin, ibuprofen, loxoprofen, naproxen, diclofenac, indomethacin, meloxicam, acetaminophen)
- •History of allergic reaction to the medications used in this study
- •Patients that investigators consider ineligible for this study
研究组 & 干预措施
Teprenone capsule
Experimental
干预措施: Teprenone capsule and placebo of sucralfate (Drug)
sucralfate
Active Comparator
干预措施: Sucralfate and placebo of teprenone (Drug)
结局指标
主要结局
The difference of the modified Lanza score after 4 weeks of treatment between teprenone group and sucralfate group
时间窗: 0,4 weeks
次要结局
- The difference of total effective rate after 4 weeks treatment evaluated by histologic examination on inflammation improvement between teprenone group and sucralfate group(4 weeks)
- The difference of total effective rate after 4 and 8 weeks treatment evaluated by clinical symptom score between teprenone group and sucralfate group(4 and 8 weeks)
- The difference of patients' gastric mucosal concentration of hexosamine, PGE2 and HSP70 after 4 weeks treatment between teprenone group and sucralfate group(4 weeks)
- The difference of total effective rate after 8 weeks treatment evaluated by endoscopy between teprenone group and sucralfate group(8 weeks)
研究者
研究点 (8)
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