Efficacy of 4-week Mosapride compared to Domperidone with twice daily Proton pump inhibitor in Systemic Sclerosis patients with Gastro-esophageal Reflux Disease

Phase 3

• Conditions: Systemic sclerosis with GERD; Systemic sclerosis; GERD; Gastrointestinal Reflux Disease; Refractory GERD; Efficacy; Mosapride; Gasmotin; Domperidone; Motilium

• Registration Number: TCTR20240509002
• Lead Sponsor: Thai Rheumatism Association

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-09
• Last Update Posted: 19 August 2024
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 160

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The changes in scores of the Frequency Scale for Symptoms of GERD (FSSG): Reflux score 4 weeks Score of Questionnaire

Secondary Outcome Measures

Name	Time	Method
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