Gastroesophageal Reflux Treatment in Scleroderma (GERD-SSc)

Khon Kaen University

Status and phase: Completed; Phase 3

Conditions: Scleroderma; Systemic Sclerosis; Gastroesophageal Reflux Disease

Treatments: Drug: Alginic acid; Drug: Domperidone; Drug: placebo (of alginic acid); Drug: placebo (for domperidone)

Study type: Interventional

Funder types: Other

Identifiers

NCT01878526

GERD therapy in scleroderma

PPI in SSc-GERD (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Omeprazole plus alginic acid and placebo of domperidone

Experimental group

Treatment:

Drug: placebo (for domperidone)

Drug: Alginic acid

Omeprazole plus domperidone and placebo of alginic acid

Experimental group

Treatment:

Drug: placebo (of alginic acid)

Drug: Domperidone