Erosive esophagitis is commonly seen in systemic sclerosis and significantly impacts patients'
Conditions
Interventions
Vonoprazan 20 mg once daily with a placebo of lansoprazole once daily for 8 weeks.,Lansoprazole 30 mg once daily with a placebo of vonoprazan once daily for 8 weeks.
Active Comparator Drug,Active Comparator Drug
Vonoprazan,Lansoprazole
Sponsors
Witsarut Manasirisuk
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Scleroderma patients will be diagnosed based on the 2013 American College of Rheumatology criteria. 2. Patients must have refractory gastroesophageal reflux disease (GERD), defined as a lack of response to more than eight weeks of high-dose acid suppression therapy. 3. Patients must have erosive esophagitis confirmed by upper gastrointestinal endoscopy, classified according to the Los Angeles classification (grades A-D).
Exclusion criteria
Exclusion criteria: 1. Allergy to vonoprazan or lansoprazole2. 2. Prior treatment with vonoprazan or lansoprazole 3. Pregnancy 4. History of erosive esophagitis, as defined by upper gastrointestinal (UGI) endoscopy 5. Contraindication for UGI endoscopy 6. Active malignancy 7. Uncontrolled medical conditions, including: 7.1 Severe heart failure (New York Heart Association [NYHA] functional class III or IV) 7.2 Severe COPD (GOLD stages C or D) 7.3 Advanced chronic kidney disease (CKD stages G4 or G5) 7.4 Active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing of erosive esophagitis 8 weeks UGI endoscopy to confirm healing | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of erosive esophagitis 8 weeks UGI endoscopy to confirm improvement (defined by Los-Angeles classification),Clinical of reflux disease 8 weeks Questionaire about reflux symptoms (FSSG, GERDQ)),Quality of life 8 weeks EQ5D | — |
Countries
Thailand
Contacts
Public ContactWitsarut Manasirisuk
Khon Kaen University, Thailand
Outcome results
None listed