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Gastroesophageal Reflux Disease | Gastroesophageal Reflux Treatment in Scleroderma

Gastroesophageal Reflux Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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: 1. SSc patients aged between 18 and 65 years. 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 Exclusion criteria: 1. Pregnancy or lactation 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 Phase 2 randomized parallel study SSc patients who fit all inclusion and exclusion criteria will be eligible to phase 2 study. Inclusion criteria: 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: 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Gastroesophageal Reflux Disease

Systemic Sclerosis

Scleroderma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Alginic acidAlgycon 1 tab chew tid after meal

Drug:placebo (for domperidone)placebo (for domperidone) 1 tab oral tid before meal

Drug:Domperidonedomperidone (10 mg) 1 tab oral tid before meal

Drug:placebo (of alginic acid)placebo (for alginic acid) 1 tab chew tid after meal

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Omeprazole plus alginic acid and placebo of domperidone

Omeprazole plus domperidone and placebo of alginic acid

Study Status

Completed

Start Date: June 2013

Completed Date: January 2016

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)

Secondary Outcome: Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)

Study sponsors, principal investigator, and references

Principal Investigator: Chingching Foocharoen, MD

Lead Sponsor: Khon Kaen University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01878526

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