NL-OMON53662招募中2 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 - MOVE-IT
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
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
- 年龄范围
- 18 至 99(—)
入选标准
- •Men and women between >=18 and <=75 years of age
- •History of idiopathic or diabetic gastroparesis cardinal symptoms for >= 3
- •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
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
- •Active 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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