EUCTR2020-004723-17-BE
Active, not recruiting
Phase 1
Clinical usefulness and influence on oesophageal motility of pyridostigminefor dysphagia in systemic sclerosis. - PySys
Z Brussel0 sites25 target enrollmentJanuary 18, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Dysphagia by patients suffering from systemic sclerosis
- Sponsor
- Z Brussel
- Enrollment
- 25
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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