Systemic sclerosis with GERD Systemic sclerosis GERD Gastrointestinal Reflux Disease Refractory GERD Efficacy Mosapride Gasmotin Domperidone Motilium Omeprazole
Conditions
Interventions
A selective 5-HT4 receptor agonist
Dose 5 mg per oral, before each meals, three times a day
with twice daily proton pump inhibitor,A dopamine D2 receptor antagonist
Dose 10 mg per oral, before each me
Experimental Drug,Active Comparator Drug
Sponsors
Thai Rheumatism Association
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with systemic sclerosis based on the 2013 American College of Rheumatology/The European Alliance of Associations for Rheumatology (ACR/EULAR) criteria 2. Patients aged 18 years or older 3. Patients diagnosed with newly diagnosed gastroesophageal reflux disease (GERD) with a GERD-Q score greater than or equal to 8 points, and when treated with omeprazole, 20 mg twice daily before breakfast and dinner, still have a GERD-Q score greater than or equal to 8 points, or patients diagnosed with GERD who have been treated with omeprazole, 20 mg twice daily before breakfast and dinner, and still have a GERD-Q score greater than or equal to 8 points 4. Patients who have not received prokinetic drugs for at least 2 weeks prior to baseline assessment before starting the study 5. If patients were previously taking domperidone (in cases diagnosed with GERD previously treated with omeprazole and domperidone), they will enter a wash-out period lasting 2 weeks and may still qualify for study participation
Exclusion criteria
Exclusion criteria: 1. Pregnant individuals (in cases where female volunteers still menstruate, pregnancy testing will be conducted before considering enrollment in the research project) 2. Breastfeeding individuals 3. Individuals with a history of surgery in the esophagus or stomach 4. Individuals with a history of upper gastrointestinal endoscopy procedure 5. Individuals with a history of upper gastrointestinal endoscopy showing Barrett's esophagus 6. Bedridden individuals who cannot assist themselves 7. Individuals with active cancer 8. Individuals with chronic diseases that are difficult to control or severe, such as asthma at any stage, chronic obstructive pulmonary disease (COPD) at any stage, acute and chronic ischemic heart disease not treated with revascularization, acute and chronic heart failure, Child-Pugh class B-C liver cirrhosis, stage 4-5 chronic kidney disease 9. Individuals with acute infections, including acute bacterial infections, acute viral infections, tuberculosis and other non-tuberculous mycobacterial infections under treatment, invasive fungal infections (e.g., bloodstream infections, pulmonary infections) under treatment 10. Individuals with mental illness who cannot control their symptoms 11. Individuals with a history of severe food allergies (anaphylaxis) that may cause gastrointestinal side effects 12. Individuals with a history of medication that may affect the evaluation of GERD symptoms (e.g., non-steroidal anti-inflammatory drugs, tetracycline antibiotics, isoniazid, iron supplements, digoxin, bisphosphonates) 13. Individuals with chewing difficulties 14. Individuals with a history of head and neck radiation therapy 15. Individuals with abnormal sensations in the chest area (e.g., nerve related chest pain radiating along the chest wall) 16. Individuals diagnosed with Celiac disease 17. Individuals with a history of abnormal heart electrical activity in the form of QT prolongation (male volunteers QTc more than or equal to 450 msec, female volunteers more than or equal to 460 msec)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in scores of the Frequency Scale for Symptoms of GERD (FSSG): Reflux score 4 weeks Score of Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in scores of the Frequency scale for symptoms of GERD (FSSG): Dysmotility score 4 weeks Score of Questionnaire,The changes in scores of the Reflux Disease Questionnaire 4 weeks Score of Questionnaire,The changes in scores of the VAS of heartburn 4 weeks Scores,The changes in scores of the VAS of regurgitation 4 weeks Scores,The changes in score of the VAS of night cough 4 weeks Scores,Safety of prokinetic drugs 4 weeks Volunteer numbers of each side effects | — |
Countries
Thailand
Contacts
Public ContactNicha Saejung
Siriraj Hospital, Mahidol University
Outcome results
None listed