Gastroesophageal Reflux Treatment in Scleroderma

Phase 3

Completed

Interventions: Drug: Alginic acid
Drug: Domperidone
Drug: placebo (for domperidone)
Drug: placebo (of alginic acid)

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Omeprazole plus alginic acid and placebo of domperidone	Alginic acid	-
Omeprazole plus alginic acid and placebo of domperidone	placebo (for domperidone)	-
Omeprazole plus domperidone and placebo of alginic acid	Domperidone	-
Omeprazole plus domperidone and placebo of alginic acid	placebo (of alginic acid)	-

Primary Outcome Measures

Name	Time	Method
Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)	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.
Changing of the Severity of Regurgitation	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.

Secondary Outcome Measures

Name	Time	Method
Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)	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.
the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole	4 weeks
Changing of the Quality of Life Which is Evaluated by EQ-5DTM	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.