Status:
WITHDRAWN
Clinical Usefulness and Influence on Esophageal Motility of Pyridostigmine for Dysphagia in Systemic Sclerosis
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Systemic Sclerosis With Dysphagia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Systemic sclerosis is characterized by progressive fibrosis of different organ systems. With a longer duration, the risk of gastrointestinal involvement increases. There is a high prevalence of gastro...
Eligibility Criteria
Inclusion
- Patients aged 18 years or older;
- Known systemic sclerosis;
- Dysphagia with BEDQ score of 10 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.).
Exclusion
- Presence of reflux oesophagitis grade C or more, eosinophilic oesophagitis, oesophageal stenosis (whether peptic or malignant);
- Prior oesophageal surgery, endoscopic resections, Radiofrequency Abla-tion for Barrett's mucosa or POEM;
- Prior gastric surgery;
- Prior diagnosis of major oesophageal motor disorder such as oesophageal spasm, achalasia, EGJ 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;
- Prior or current urinary obstruction;
- Previous treatment with pyridostigmine in the past 4 weeks;
- Treatment with anticholinergic agents in the past 4 weeks;
- Treatment with prokinetic agents during the past 4 weeks
- Pregnancy. Women of childbearing age will undergo a pregnancy test be-fore starting treatment and will be required to use at least 2 highly effective anticonception methods.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06915181
Start Date
December 1 2023
End Date
May 1 2024
Last Update
April 8 2025
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