Pantoprazole Versus Famotidine for the Prevention of Recurrent Peptic Ulcers in Thienopyridine Users - a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Number of Participants With Ulcer Recurrence
研究概览
简要总结
Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in thienopyridine users remains unclear.
详细描述
The aims of the randomized double-blind comparison study are to compare the efficacy of Proton Pump Inhibitor and H2 receptor antagonist for the prevention of recurrent peptic ulcers in thienopyridine users. We plan to enroll 334 thienopyridine (clopidogrel or ticlopidine) users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) pantoprazole (40 mg qd) or (2) famotidine (40 mg qd) for 6 months.The ulcer recurrence rate between the treatment groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent endoscopic examination (within 2 months) reveals normal appearance or erythematous patches only (without subepithelial hemorrhages, erosions or ulcers).
- •Peptic ulcers (a mucosal break ³ 5 mm in diameter) have been documented by a previous endoscopic examination.
- •Subjects have received thienopyridine therapy for at least two weeks.
- •Requiring long-term anti-platelet therapy for ischemic cardiovascular diseases.
排除标准
- •A history of gastric or duodenal surgery other than oversewing of a perforation.
- •Subjects who are allergic to the study drugs.
- •Requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, aspirin, or anticoagulant agents.
- •Pregnancy.
- •Subjects who have active cancer, acute serious medical illness or terminal illness.
- •Subjects who have gastroesophageal reflux disease.
研究组 & 干预措施
proton pump inhibitor group
Pantoprazole Tab 40mg qd for 6 monthrs.
干预措施: proton pump inhibitor group (Drug)
histamine-2 receptor antagonist group
famotidine Tab 40 mg qd for 6 months.
干预措施: histamine-2 receptor antagonist group (Drug)
结局指标
主要结局
Number of Participants With Ulcer Recurrence
时间窗: six month
Follow-up endoscopy was performed at the end of the 6th month
次要结局
未报告次要终点
研究者
Ping-I (William) Hsu, M.D.
Professor
Kaohsiung Veterans General Hospital.