Dyspeptic Symptoms Evolution After Eradication of Helicobacter Pylori in Patients With Different Endoscopic Findings: a Randomized Double-blind Placebo-controlled Clinical Trial With 12 Months of Follow-up
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire
研究概览
简要总结
A double-blind clinical trial investigating if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradication than the placebo control group
详细描述
Objective: investigate if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradication than the placebo control group
Design: A randomized double-blind placebo controlled clinical trial
Inclusion Criteria: Patients with more than 18 years, Functional dyspepsia accordingly Rome III criteria, Helicobacter pylori infection by two diagnostic tests
Exclusion Criteria: No concordance with informed consent; Pregnant woman or breast feeding or no trust anticonceptional method; Structural gastrointestinal abnormalities except gastritis, duodenitis or hiatal hernia; Previous treatment for Helicobacter pylori infection; Previous surgery on esophagus, stomach or duodenum; Hypersensitivity to the drugs in study; Proton pump inhibitor use in the previous 15 days; H2-antagonists use in the previous 07 days; Antibiotics use in the previous 30 days; Patients unable to answer the study questionnaires; Alcohol abuse; Drug use; Serious comorbidities; Biliary colic; Irritable bowel syndrome; Gastroesophageal Reflux Disease
Interventions: amoxicillin, clarythromycin, omeprazole for 10 days
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
- •Patients with more than 18 years
- •Functional dyspepsia accordingly Rome III criteria
- •Helicobacter pylori infection by two diagnostic tests
排除标准
- •No concordance with informed consent
- •Pregnant woman or breast feeding or no trust anticonceptional method
- •Structural gastrointestinal abnormalities except gastritis, duodenitis or hiatal hernia
- •Previous treatment for Helicobacter pylori infection
- •Previous surgery on esophagus, stomach or duodenum
- •Hypersensitivity to the drugs in study
- •Proton pump inhibitor use in the previous 15 days
- •H2-antagonists use in the previous 07 days
- •Antibiotics use in the previous 30 days
- •Patients unable to answer the study questionnaires
- •Alcohol abuse
- •Serious comorbidities
- •Biliary colic
- •Irritable bowel syndrome
- •Gastroesophageal Reflux Disease
研究组 & 干预措施
1
Amoxicillin 1000 mg BID, clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days
干预措施: Amoxicillin, Clarythromycin, Omeprazole for ten days (Drug)
2
Placebo of Amoxicillin 1000 mg BID, placebo of clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days
干预措施: Amoxicillin, Clarythromycin, Omeprazole for ten days (Drug)
结局指标
主要结局
Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire
时间窗: the last visit among the antecipated visits (4, 8 and 12 months)
次要结局
- Lost of productivity measured by WPAI between groups(12 months)
- Adverse Events(4 , 8 and 12 months)
- Proportion of patients with 100% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire(the last visit among the antecipated visits (4, 8 and 12 months))
- Need of rescue medication(4, 8 and 12 months)
- Median difference of score between groups(the last visit among the antecipated visits (4, 8 and 12 months))
- Mean SF-36 scores evolution between groups(12 months)