EUCTR2021-002254-86-PL进行中（未招募）1 期
Double-blind, randomised, placebo-controlled, dose-finding phase IIb trial to evaluate the efficacy, safety, and tolerability of a 12-week-treatment with Naronapride in adult participants with at least moderate idiopathic or diabetic gastroparesis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Men and women between =18 and =75 years of age
- •-History of idiopathic or diabetic gastroparesis cardinal symptoms for =3 months
- •-Evidence of delayed gastric emptying
- •-Average weekly total symptom score of =2.0
- •- Body Mass Index =16 and <35 kg/m2
- •- Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy/an imaging technique
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 256
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •-Participants without access to an internet-capable terminal and/or without an own e-mail address
- •-History of major gastrointestinal surgery
- •-Intrapyloric botulinum toxin injection within 12 months
- •-Gastric stimulator implant
- •-Known secondary causes of gastroparesis
- •-Presence of inflammatory bowel disease, eosinophilic oesophagitis, or reflux oesophagitis, acute gastritis
研究者
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