Phase 3
N=80
Gastroesophageal Reflux Treatment in Scleroderma
Gastroesophageal Reflux Disease · Systemic Sclerosis · Scleroderma
Bottom Line
View on ClinicalTrials.gov: NCT01878526 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS) — 17.9; 17.2 VAS (100)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Alginic acid (Drug); placebo (for domperidone) (Drug); Domperidone (Drug); placebo (of alginic acid) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Khon Kaen University
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS) |
17.9; 17.2 | — |
| PRIMARY Changing of the Severity of Regurgitation |
24.9; 23.1 | — |
| SECONDARY Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG) |
4.6; 4.7 | — |
| SECONDARY the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole |
59 | — |
| SECONDARY Changing of the Quality of Life Which is Evaluated by EQ-5DTM |
75.7; 76.1 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT01878526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.