Phase
Condition
Heartburn (Pediatric)
Esophageal Disorders
Collagen Vascular Diseases
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Phase 1 SSc patients who fit all inclusion and exclusion criteria will be eligible to phase 1 study for evaluation the prevalence of omeprazole resistant-GERD Inclusion criteria:
SSc patients aged between 18 and 65 years.
Clinically diagnosed as GERD and GERD-questionnaire score >3
Must not receive any proton pump inhibitor (PPI) or prokinetic drug within 2 weeksbefore baseline evaluation
Exclusion
Exclusion criteria:
Pregnancy or lactation
Previous history of gastroesophageal surgery or endoscopic therapy due to severeerosive esophagitis
Present of Barrett's esophagus
Bedridden and confined to no self-care
Evidence of active malignant disease
Present of uncontrolled or severe medical problems such as asthma, angina, hepatic orrenal diseases
Present of active infection that needs systemic antibiotic
Allergic history of omeprazole
Receiving prohibit co-medications that may have drug interaction or attenuate GERDsymptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate Phase 2 randomized parallel study SSc patients who fit all inclusion and exclusion criteriawill be eligible to phase 2 study. Inclusion criteria:
SSc patients who completed the phase 1 study.
The subjects were defined as PPI-resistance.
The subject must be willing to continue phase 2 study. Exclusion criteria:
Pregnancy
Present of uncontrolled or severe medical problems
Present of active infection
Allergic history of alginic acid or domperidone
Receiving prohibit co-medications that may have drug interaction or attenuate GERDsymptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate
Chewing difficulty
Study Design
Connect with a study center
123 Department of Medicine, Faculty of Medicine, Khon Kaen University
Khon Kaen, 40002
ThailandSite Not Available

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