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临床试验/NL-OMON53662
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

Dr. Falk Pharma GmbH0 个研究点目标入组 28 人开始时间: 待定最近更新:

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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