Esomeprazole or Famotidine in the Management of Aspirin Related Non-ulcer Dyspepsia - a Double Blind Randomized Control Study
试验速览
- 阶段
- 4 期
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Treatment success : The HKDI is less than 16. Treatment was considered to have failed if a patient had taken medication for dyspepsia (other than antacids) during the study period
研究概览
简要总结
Aspirin can prevent ischemic vascular disease but is commonly complicated by dyspepsia in 30% of patients. Patients, who have aspirin related dyspepsia, commonly underwent upper endoscopy to exclude peptic ulcer disease or gastric cancers. For those without significant lesions in the stomach and duodenum (non-ulcer dyspepsia), the best approach in the management is unclear. The objective of this study is to compare the efficacy of esomeprazole and famotidine in the control of dyspeptic symptom. After giving consent, patients will be randomised to receive either esomeprazole 20 mg daily or famotidine 40 mg daily in a double blinded manner. The patient will be followed-up at the 2nd and 4th week. The study will be completed at the 4th week. The primary analysis will be the efficacy in the control of dyspepsia symptom between the two groups.
详细描述
The objective of this double blinded randomized controlled study is to compare the efficacy of esomeprazole with famotidine in the control of dyspepsia in patients with aspirin related nonulcer dyspepsia NUD.
Method
The study shall be applied for approval from the Ethic Committee of Hong Kong West and East Cluster and shall be registered to the Clinical Trial Governance before the recruitment of the first patient.
Measuring instruments & Definitions
Hong Kong Dyspepsia Index (HKDI)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least moderate pain or discomfort (or both) centered in the upper abdomen as their predominant symptoms for 7 days before randomization; taking low dose aspirin (80-300 mg daily),and insignificant upper endoscopic finding. At least moderate pain or discomfort is defined if the HKDI was more than or equal to
- •H. Pylori: In patients with have successful eradication of H. pylori and had dyspepsia with HKDI >=16 at the 6th week after eradication therapy can be recruited.In patients without H. pylori infection, they can be recruited immediately.
排除标准
- •non-Chinese speaking
- •significant endoscopic finding
- •typical biliary colic
- •predominant heartburn or symptoms of the irritable bowel syndrome
- •a history of peptic ulcer or gastroesophageal reflux
- •unintentional weight loss previous gastric or duodenal surgery
- •thrombocytopenia
- •renal failure with estimated creatinine clearance less than 10 ml/min
- •active cancer
- •known allergic to aspirin, famotidine or esomeprazole
- •pregnancy, lactation, child-bearing potential in the absence of contraception
- •planned co-prescription of nonsteroidal anti-inflammatory drugs
- •corticosteroid, clopidogrel or anticoagulant
- •anxiety neurosis, depression, psychosomatic disorder
- •investigation for dyspepsia with endoscopy or barium series before aspirin therapy or disorders that might modify the absorption of study drugs
- •ongoing treatment with a histamine H2-receptor antagonist, a prostaglandin, or a prokinetic drug during the 7 days before enrollment was not permitted, nor was treatment with a proton-pump inhibitor, or bismuth in the 30 days before enrollment
研究组 & 干预措施
esomeprazole
esomeprazole 20 mg
干预措施: esomeprazole (Drug)
Famotidine
famotidine 40 mg
干预措施: Famotidine (Drug)
结局指标
主要结局
Treatment success : The HKDI is less than 16. Treatment was considered to have failed if a patient had taken medication for dyspepsia (other than antacids) during the study period
时间窗: 4 weeks
次要结局
- Treatment success: no significant dyspepsia defined by the Global Dyspepsia Score(4 weeks)