Gastroesophageal Reflux Treatment in Scleroderma (GERD-SSc)
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|ClinicalTrials.gov Identifier: NCT01878526|
Recruitment Status : Completed
First Posted : June 17, 2013
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease Systemic Sclerosis Scleroderma||Drug: Alginic acid Drug: placebo (for domperidone) Drug: Domperidone Drug: placebo (of alginic acid)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||January 2016|
U.S. FDA Resources
|Experimental: Omeprazole plus alginic acid and placebo of domperidone||
Drug: Alginic acid
Algycon 1 tab chew tid after meal
Other Name: AlgyconDrug: placebo (for domperidone)
placebo (for domperidone) 1 tab oral tid before meal
|Experimental: Omeprazole plus domperidone and placebo of alginic acid||
domperidone (10 mg) 1 tab oral tid before meal
Other Name: MolaxDrug: placebo (of alginic acid)
placebo (for alginic acid) 1 tab chew tid after meal
- Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS) [ 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.
- Changing of the Severity of Regurgitation [ 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.
- Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG) [ 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.
- the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole [ Time Frame: 4 weeks ]
- Changing of the Quality of Life Which is Evaluated by EQ-5DTM [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878526
|123 Department of Medicine, Faculty of Medicine, Khon Kaen University|
|Khon Kaen, Thailand, 40002|
|Principal Investigator:||Chingching Foocharoen, MD||Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand|