Gastroesophageal Reflux Treatment in Scleroderma

Study Overview
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Brief Summary
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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.

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

Conditions
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Scleroderma, Gastroesophageal Reflux Disease, Systemic Sclerosis

Intervention / Treatment
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* Drug: Alginic acid
* Drug: placebo (for domperidone)
* Drug: Domperidone
* Drug: placebo (of alginic acid)


Participation Criteria
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Eligibility Criteria
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Phase 1 SSc patients who fit all inclusion and exclusion criteria will be eligible to phase 1 study for evaluation the prevalence of omeprazole resistant-GERD Inclusion criteria: SSc patients aged between 18 and 65 years. Clinically diagnosed as GERD and GERD-questionnaire score >3 Must not receive any proton pump inhibitor (PPI) or prokinetic drug within 2 weeks before baseline evaluation Exclusion criteria: Pregnancy or lactation Previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis Present of Barrett's esophagus Bedridden and confined to no self-care Evidence of active malignant disease Present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases Present of active infection that needs systemic antibiotic Allergic history of omeprazole Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate Phase 2 randomized parallel study SSc patients who fit all inclusion and exclusion criteria will be eligible to phase 2 study. Inclusion criteria: SSc patients who completed the phase 1 study. The subjects were defined as PPI-resistance. The subject must be willing to continue phase 2 study. Exclusion criteria: Pregnancy Present of uncontrolled or severe medical problems Present of active infection Allergic history of alginic acid or domperidone Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate Chewing difficulty

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omeprazole plus alginic acid and placebo of domperidone<br> | Drug: Alginic acid<br>* Algycon 1 tab chew tid after meal<br>* Other names: Algycon;Drug: placebo (for domperidone)<br>* placebo (for domperidone) 1 tab oral tid before meal<br>|
| Experimental: Omeprazole plus domperidone and placebo of alginic acid<br> | Drug: Domperidone<br>* domperidone (10 mg) 1 tab oral tid before meal<br>* Other names: Molax;Drug: placebo (of alginic acid)<br>* placebo (for alginic acid) 1 tab chew tid after meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS) | 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. | 8 weeks | 
| Changing of the Severity of Regurgitation | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG) | 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. | 8 weeks | 
| 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 | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastroesophageal reflux disease, heart burn, regurgitation, systemic sclerosis, scleroderma, proton pump inhibitor, alginic acid, omeprazole, prokinetic