Motility disorder is the primary mechanism underlying the development of GERD in scleroderma, particularly in non-erosive reflux disease. Recent data showed that domperidone was equally effective in controlling reflux symptoms compared to alginate. However, there isn'
Conditions
Interventions
Domperidone 10 mg PO TID AC and omeprazole 20 mg PO OD AC for about 8 weeks.,Placebo PO TID AC and omeprazole 20 mg PO OD AC for about 8 weeks.
Active Comparator Drug,Placebo Comparator Drug
Domperidone plus PPI,Placebo plus PPI
Sponsors
Witsarut Manasirisuk
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: roderma patients diagnosed according to the American College of Rheumatology criteria from 2013, who have refractory gastroesophageal reflux disease defined by a lack of response to more than eight weeks of high-dose acid suppression therapy and who have undergone upper gastrointestinal endoscopy showing no erosive esophagitis.
Exclusion criteria
Exclusion criteria: Allergy to domperidone Pregnancy History of erosive esophagitis as defined by UGI endoscopy Contraindication for UGI endoscopy Active malignancy Uncontrolled medical conditions, such as: Severe heart failure (New York Heart Association [NYHA] functional class III or IV) Severe COPD (COPD GOLD stages C or D) Advanced chronic kidney disease (CKD stages G4 or G5) Active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical of GERD by FSSG and GERDQ 8 weeks after recieved medication Questionaire about reflux symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life 8 weeks after recived medication assessment by EQ5D questionaires | — |
Countries
Thailand
Contacts
Public ContactWitsarut Manasirisuk
Khon Kaen University, Thailand
Outcome results
None listed