ISRCTN96975557已完成不适用
FAMOtidine for the prevention of peptic UlcerS in users of low-dose aspirin: a placebo-controlled prospective trial
Greater Glasgow NHS Board (UK)0 个研究点目标入组 700 人开始时间: 2005年10月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult patients aged 18 years or over (either sex) and requiring low-dose aspirin, 75 - 325 mg daily
- •2. The presence of a stable and controlled indication for the anti-thrombotic effect of aspirin. This includes stable angina, previous myocardial infarction (12 or more weeks before recruitment), and peripheral vascular disease
- •3. The use of aspirin is likely to continue for 3 months or longer
- •4. The presence or absence of mild to moderate bearable dyspeptic or reflux symptoms
- •5. The presence or absence of gastric or duodenal erosions at base-line endoscopy
排除标准
- •Any of the following is regarded as criterion for exclusion from the study:
- •1. History of oesophageal, gastric or duodenal surgery, excluding simple closure of an ulcer or vagotomy
- •2. Current or historical evidence of any of the following diseases:
- •2.1. Zollinger-Ellison syndrome
- •2.2. Primary oesophageal motility disorder(s) i.e. achalasia, scleroderma, primary oesophageal spasm
- •2.3. Evidence of upper GI malignancy at the pre-study endoscopy
- •2.4. Malabsorption
- •2.5. Significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator to interfere with the evaluation of the study
- •2.6. Unstable diabetes mellitus (stable diabetes controlled by diet, oral agents or insulin is not an exclusion criterion)
- •2.7. Cerebrovascular disease such as cerebral ischaemia, infarction, haemorrhage or embolus as judged by the investigator to interfere with the evaluation of the study
- •2.8. Erosive oesophagitis at base-line endoscopy
- •2.9. Gastric ulcer and/or duodenal ulcer at base-line endoscopy or within the last 3 months
- •2.10. Inflammatory bowel disease
- •3. Suspected or confirmed current malignancy, except minor superficial skin disease
- •4. Complications related to gastroesophageal reflux disease (GORD) such as oesophageal stricture or confirmed low/high grade dysplasia of the oesophagus
- •5. Pregnancy or lactation. Women of childbearing potential will be required to maintain effective contraception during the study period as judged by the investigator.
- •6. Use of proton pump inhibitors, H2 receptor antagonists, or sucralfate within a week of the initial endoscopy
- •7. Treatment with a recognised H.pylori eradication regimen in the 28 days prior to Visit 1
- •8. Use of any other investigational compound or participation in another clinical trial within the 90 days prior to start of study medication
- •9. Need for continuous concomitant therapy with:
- •9.1. Anticholinergics (excluding eye drops and inhaled anticholinergics)
- •9.2. Cisapride
- •9.3. Prostaglandin analogues
- •9.4. Warfarin
- •9.5. High dose steroids (more than 7.5 mg of prednisolone or its equivalent daily)
- •9.6. Cytotoxic drugs
- •9.7. Non-steroidal anti-inflammatory drugs
- •9.8. Bisphosphonates used in the treatment or prevention of osteoporosis
- •10. Alcohol and/or drug abuse or any condition associated with poor compliance including expected non-cooperation, as judged by the investigator
- •11. Previous participation in this study
- •12. Contraindications to study drugs e.g. known or suspected allergy to famotidine
- •13. Need for interpreter (patients must be able to understand and complete the questionnaires in English)
研究者
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