A clinical trial to evaluate the improvement of swallowing problemsexperienced by patients suffering from systemic sclerosis bypyridostigmine.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 25

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
F.1.3.1 Number of subjects for this age range

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
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
weeks;
- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study aims to evaluate the improvement of dysphagia experienced<br>by patients suffering from systemic sclerosis by pyridostigmine.;Secondary Objective: Secondarily, as esophageal dysmotility results in impaired clearance of<br>refluxate, the influence of pyridostigmine on the severity of symp-toms<br>of gastro-esophageal reflux disease will be assessed.;Primary end point(s): The primary endpoint is the number of patients with improvement of<br>Eckardt score to 3 or less (which is widely accepted as absence of significant<br>dysphagia).;Timepoint(s) of evaluation of this end point: 4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Changes of Eckardt score from baseline will be compared be-tween<br>both treatment arms;<br>- Changes in HRM (high resolution manometry) parameters from<br>baseline: Increase in Distal Contractility Integral, in-crease in<br>Integrative Relaxatory Pressure 4s, increase in the percentage of<br>successful bolus clearance, decrease in number of failed peristalsis,<br>increase in the percentage of normal peri-stalsis;<br>- Decrease in GERD-FSSG;<br>- Improvement in the score of the SF-36 QOL questionnaire;<br>- Comparison of the occurrence of side effects.;Timepoint(s) of evaluation of this end point: At the end of the study