NCT01878526

Gastroesophageal Reflux Treatment in Scleroderma

The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux Disease
• Systemic Sclerosis
• Scleroderma

Interventions

Type	Name	Description
DRUG	Alginic acid	Algycon 1 tab chew tid after meal
DRUG	placebo (for domperidone)	placebo (for domperidone) 1 tab oral tid before meal
DRUG	Domperidone	domperidone (10 mg) 1 tab oral tid before meal
DRUG	placebo (of alginic acid)	placebo (for alginic acid) 1 tab chew tid after meal

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-08-01
• Completion: 2016-01-01
• First posted: 2013-06-17
• Last updated: 2017-03-27
• Results posted: 2017-03-27

Locations

1 site across 1 country: Thailand