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临床试验/CTIS2023-510195-31-00
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

Dr. Falk Pharma GmbH0 个研究点目标入组 318 人开始时间: 2024年6月28日最近更新:

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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