The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis (GERD-SSc)

NCT01878526 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Khon Kaen University
Phase	Phase 3
Status	COMPLETED
Enrolment	80
Start date	2013-06
Completion	2016-01

Conditions

• Gastroesophageal Reflux Disease
• Systemic Sclerosis
• Scleroderma

Interventions

• Alginic acid
• placebo (for domperidone)
• Domperidone
• placebo (of alginic acid)

Primary outcomes

• 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.

Countries

Thailand