NCT00526006Unknown4 期
PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena
适应症
相关药物
试验速览
- 阶段
- 4 期
- 试验地点
- 2
- 主要终点
- Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group
研究概览
简要总结
The acid secretion in the stomach seems to increase after withdrawal of min. 8 wks of treatment with a PPI (protonpump inhibitor) It is unknown if this acid rebound phenomenon is of clinical significance. In a doubleblinded and placebocontrolled study healthy volunteers are randomized to treatment with placebo or PPI + placebo. Gastrointestinal symptoms are scored once a week and.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years +
排除标准
- •Dyspepsia, heartburn og acid regurgitation within the preceeding 4 weeks
- •Previous treatment with PPI og H2RA
- •Previous contact to doctor or hospital because of dyspepsia or reflux
- •Pregnancy or breast feeding
结局指标
主要结局
Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group
次要结局
未报告次要终点
研究者
研究点 (2)
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