Dysphagia by patients suffering from systemic sclerosis
Conditions
Interventions
Trade Name: Mestinon (pyridostigmine bromide)
Pharmaceutical Form: Tablet
INN or Proposed INN: PYRIDOSTIGMINE BROMIDE
CAS Number: 101-26-8
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
UZ Brussel
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aims to evaluate the improvement of dysphagia experienced by patients suffering from systemic sclerosis by pyridostigmine.;Secondary Objective: Secondarily, as esophageal dysmotility results in impaired clearance of refluxate, the influence of pyridostigmine on the severity of symp-toms of gastro-esophageal reflux disease will be assessed.;Primary end point(s): The primary endpoint is the number of patients with improvement of Eckardt score to 3 or less (which is widely accepted as absence of significant dysphagia).;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes of Eckardt score from baseline will be compared be-tween both treatment arms; - Changes in HRM (high resolution manometry) parameters from baseline: Increase in Distal Contractility Integral, in-crease in Integrative Relaxatory Pressure 4s, increase in the percentage of successful bolus clearance, decrease in number of failed peristalsis, increase in the percentage of normal peri-stalsis; - Decrease in GERD-FSSG; - Improvement in the score of the SF-36 QOL questionnaire; - Comparison of the occurrence of side effects.;Timepoint(s) of evaluation of this end point: At the end of the study | — |
Countries
Belgium
Contacts
Public ContactProf. Dr. S. Kindt
UZ Brussel
Outcome results
None listed