Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2013-06-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Omeprazole plus alginic acid and placebo of domperidone
Alginic acid
Algycon 1 tab chew tid after meal
placebo (for domperidone)
placebo (for domperidone) 1 tab oral tid before meal
Omeprazole plus domperidone and placebo of alginic acid
Domperidone
domperidone (10 mg) 1 tab oral tid before meal
placebo (of alginic acid)
placebo (for alginic acid) 1 tab chew tid after meal
Interventions
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Alginic acid
Algycon 1 tab chew tid after meal
placebo (for domperidone)
placebo (for domperidone) 1 tab oral tid before meal
Domperidone
domperidone (10 mg) 1 tab oral tid before meal
placebo (of alginic acid)
placebo (for alginic acid) 1 tab chew tid after meal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinically diagnosed as GERD and GERD-questionnaire score \>3
3. Must not receive any proton pump inhibitor (PPI) or prokinetic drug within 2 weeks before baseline evaluation
1. SSc patients who completed the phase 1 study.
2. The subjects were defined as PPI-resistance.
3. The subject must be willing to continue phase 2 study.
Exclusion Criteria
2. Previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis
3. Present of Barrett's esophagus
4. Bedridden and confined to no self-care
5. Evidence of active malignant disease
6. Present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases
7. Present of active infection that needs systemic antibiotic
8. Allergic history of omeprazole
9. Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate
1. Pregnancy
2. Present of uncontrolled or severe medical problems
3. Present of active infection
4. Allergic history of alginic acid or domperidone
5. Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate
6. Chewing difficulty
18 Years
65 Years
ALL
No
Sponsors
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Khon Kaen University
OTHER
Responsible Party
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Chingching Foocharoen
Associate Professor
Principal Investigators
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Chingching Foocharoen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
Locations
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123 Department of Medicine, Faculty of Medicine, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, Thailand
Countries
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References
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Foocharoen C, Chunlertrith K, Mairiang P, Mahakkanukrauh A, Suwannaroj S, Namvijit S, Wantha O, Nanagara R. Effectiveness of add-on therapy with domperidone vs alginic acid in proton pump inhibitor partial response gastro-oesophageal reflux disease in systemic sclerosis: randomized placebo-controlled trial. Rheumatology (Oxford). 2017 Feb;56(2):214-222. doi: 10.1093/rheumatology/kew216. Epub 2016 May 13.
Other Identifiers
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PPI in SSc-GERD
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GERD therapy in scleroderma
Identifier Type: -
Identifier Source: org_study_id
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