EUCTR2020-004723-17-BE进行中（未招募）1 期
Clinical usefulness and influence on oesophageal motility of pyridostigminefor dysphagia in systemic sclerosis. - PySys
Z Brussel0 个研究点目标入组 25 人开始时间: 2021年1月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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
- 性别
- All
入选标准
- •- Patients aged 18 years or older;
- •- Known systemic sclerosis;
- •- Dysphagia with Eckardt score 5 or more despite twice daily high dose
- •PPI (omeprazole 40 mg b.i.d., esomeprazole 20 mg b.i.d., pantoprazole
- •40 mg b.i.d., lansoprazole 30 mg b.i.d.).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Presence of reflux oesophagitis grade C or more, eosinophilic
- •oesophagitis, organic stenosis (whether peptic or malignant);
- •- Prior oesophageal surgery, endoscopic resections, Radiofre-quency
- •Ablation for Barrett's mucosa or POEM;
- •- Prior gastric surgery;
- •- Prior diagnosis of major oesophageal motor disorder such as
- •oesophageal spasm, achalasia, EGJ(esophagogastric junction) outflow
- •obstruction
- •Prevention of major side effects by exclusion of certain patient groups:
- •- Diarrhoea (defined as Bristol Stool Scale > 5) for more than 2 days
- •per week in the past 2 weeks;
- •- Uncontrolled asthma, exacerbation of COPD in the last 4 weeks;
- •- Known ischaemic heart condition or myocardial infarction in the last 4
- •- Resting heart rate < 60 bpm;
- •- AV-block 2 or 3 (except after implantation of a pacemaker), or
- •bradycardia < 60 bpm;
- •- Systolic blood pressure > 100 mmHg;
- •- Impaired renal function with glomerular filtration rate < 30 ml/min;
- •- Previous treatment with pyridostigmine in the past 4 weeks;
- •- Treatment with anticholinergic agents in the past 4 weeks;
- •- Pregnancy. Women of childbearing age will undergo a preg-nancy test
- •before starting treatment and will be required to use at least 2 highly
- •effective anticonception methods.
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