Therapeutic Response to Lansoprazole Among Different Subgroups of Functional Dyspepsia: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- complete relief of dyspeptic symptoms
研究概览
简要总结
Pharmacotherapy for functional dyspepsia remains unsatisfactory. Previous randomized trials reported conflicting results on clinical effectiveness of proton pump inhibitor in patients with functional dyspepsia. This study aims to examine whether lansoprazole 15mg is more effective than placebo for functional dyspepsia in Taiwanese patients, and to investigate the association between subgroups of patients and therapeutic response.
详细描述
This is a prospective double-blind randomized placebo-controlled trial. A total of 450 dyspeptic adult patients, who are diagnosed with functional dyspepsia in accordance with Rome III criteria, are randomly allocated in a 1:1 proportion to receive either lansoprazole 15mg or placebo once daily for 8 weeks. Primary outcome is complete relief of dyspeptic symptoms. Secondary outcomes include significant symptomatic relief, improvement of dyspepsia severity, and health-related quality of life. We use a multiple logistic regression analysis to investigate whether dyspepsia subgroups are associated with different therapeutic responses.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dyspeptic adult outpatients
- •Characteristic dyspeptic symptoms according to Rome III criteria (bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning)
- •Upper gastrointestinal endoscopy excluding structural diseases
排除标准
- •aged less than 20 years old,
- •organic lesions such as peptic ulcer, tumor of any kind, stricture or structural deformity, erosive esophagitis, or vasculopathy on endoscopy
- •typical and predominant reflux symptoms (heartburn or acid regurgitation)
- •comorbidity with malignancy, diabetes mellitus, liver cirrhosis, renal failure, or porphyria
- •history of intra-abdominal surgery
- •concurrent use of aspirin, non-steroidal anti-inflammatory drug or proton pump inhibitor
- •history of allergy or severe side effects to lansoprazole
- •pregnant or lactating women.
研究组 & 干预措施
lansoprazole
lansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks
干预措施: Lansoprazole (Drug)
placebo
placebo once daily for eight weeks
干预措施: placebo (Drug)
结局指标
主要结局
complete relief of dyspeptic symptoms
时间窗: within one week after complete study medication
次要结局
- satisfactory therapeutic response (complete or marked relief of symptoms)(within one week after complete study medication)
- change of dyspepsia severity as measured by total scores of Hong Kong index(within one week after completing study medication)
- health-related quality of life as reflected in every aspect of SF-36(within one week after completing study medication)