CTRI/2017/11/010421招募中未知
Real world, Non-interventional, Observational Study of acotiamide hydrochloride hydrate in functional dyspepsia
试验速览
- 阶段
- 未知
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Patients clinically diagnosed with functional dyspepsia where physician has taken decision to prescribe acotiamide hydrochloride hydrate.
- •2.Patients with Functional Dyspepsia as defined by Rome III criteria
- •Diagnostic criteria Must include: One or more of the following:
- •a. Bothersome postprandial fullness
- •b. Early satiation
- •c. Epigastric pain
- •d. Epigastric burning
- •and No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms
- •Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
排除标准
- •1.Patients with a known or suspected hypersensitivity to acotiamide or to any ingredients of the formulation
- •2.Patients on cholinergic drugs as part of therapy
- •3.Patients on prokinetics as a part of therapy
- •4.Structural lesion evident in endoscopy
- •5.Coexisting Irritable bowel syndrome
- •6.Heartburn in past 12 weeks
- •7.Pregnant and lactating women
研究者
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