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临床试验/NL-OMON20470
NL-OMON20470已完成不适用

A randomized, double-blind, placebo-controlled, multicenter trial to evaluate the clinical efficacy of a single intrapyloric injection of botulinum toxin type A (Botox®) in patients with Idiopathic Gastroparesis. The BIG study.

eiden University Medical Center (LUMC), Department of Gastroenterology & Hepatology0 个研究点目标入组 48 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48

研究概览

简要总结

/A

研究设计

研究类型
Interventional

入排标准

入选标准

  • Patients are eligible to participate in this study if all of the following criteria are met:
  • 1. Presence of clinical symptoms associated with idiopathic gastroparesis; nausea, vomiting, early satiety, postprandial fullness and a GCSI score ≥ 1 at Visit 1b (eligibility; week -1);

排除标准

  • Patients are excluded from the study if any of the following criteria are met:
  • 1. Patients with predominant abdominal pain/discomfort in the opinion of the investigator;

研究者

发起方
eiden University Medical Center (LUMC), Department of Gastroenterology & Hepatology

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A randomized, double-blind, placebo-controlled,... | 临床试验