Status:
COMPLETED
Gastroesophageal Reflux Treatment in Scleroderma
Lead Sponsor:
Khon Kaen University
Conditions:
Gastroesophageal Reflux Disease
Systemic Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 combinatio...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01878526
Start Date
June 1 2013
End Date
January 1 2016
Last Update
March 27 2017
Active Locations (1)
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1
123 Department of Medicine, Faculty of Medicine, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, Thailand, 40002