Gastroesophageal Reflux Treatment in Scleroderma
Condition: Gastroesophageal Reflux Disease; Systemic Sclerosis; Scleroderma
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: Alginic acid; placebo (for domperidone); Domperidone; placebo (of alginic acid)
Intervention description: Algycon 1 tab chew tid after meal; placebo (for domperidone) 1 tab oral tid before meal; domperidone (10 mg) 1 tab oral tid before meal; placebo (for alginic acid) 1 tab chew tid after meal
Intervention MeSH terms: Domperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: gastroesophageal reflux disease; heart burn; regurgitation; systemic sclerosis; scleroderma; proton pump inhibitor; alginic acid; omeprazole; prokinetic

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.
    

Eligibility criteria:

        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