CTIS2023-510195-31-00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 - NAT-19/GPX
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 318
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 65+(—)
- 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
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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