123 Department of Medicine, Faculty of Medicine, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002, Thailand
NCT Number: NCT01878526
The investigators purposes are to define the prevalence of omeprazole resistance gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Khon Kaen, Changwat Khon Kaen, 40002, Thailand
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Exclusion criteria
Phase 2 randomized parallel study SSc patients who fit all inclusion and exclusion criteria will be eligible to phase 2 study.
Inclusion criteria
Exclusion criteria
Algycon 1 tab chew tid after meal
Other names: Algycon
placebo (for domperidone) 1 tab oral tid before meal
domperidone (10 mg) 1 tab oral tid before meal
Other names: Molax
placebo (for alginic acid) 1 tab chew tid after meal
Time frame: 8 weeks
VAS scale 0-100 was applied for an outcome measurement of the severity of heart burn. The VAS scale 0 was no symptoms of heart burn and scale 100 was a maximum symptom of heart burn. The changing of the severity of heart burn was the changing of VAS before and after treatment.
Time frame: 8 weeks
VAS scale 0-100 was applied for an outcome measurement of the severity of regurgitation. The VAS scale 0 was no symptoms of regurgitation and scale 100 was a maximum symptom of regurgitation. The changing of the severity of regurgitation was the changing of VAS before and after treatment.
Time frame: 8 weeks
Unit scale 0-48 was applied for an outcome measurement of the frequency of symptoms. The unit scale 0 was no symptom and scale 48 was usual symptom of GERD. The changing of the frequency of symptoms was the changing of the unit scale before and after treatment.
Time frame: 4 weeks
Time frame: 8 weeks
VAS scale 0-100 was applied for an outcome measurement of the quality of life. The VAS scale 0 was the worst quality of life and scale 100 was the best quality of life. The changing of the quality of life was the changing of VAS of quality of life before and after treatment.
Khon Kaen University
Other
The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis
Acronym: GERD-SSc
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