Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis

Khon Kaen University

Status and phase: Completed; Phase 1

Conditions: Proton Pubm Inhibitor; Systemic Sclerosis; Gastroesophageal Reflux

Treatments: Drug: Omeprazole 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03561233

PPI partial response GERD SSc

Details and patient eligibility

About

Proton pump inhibitor (PPI) twice daily dosing regimen-a standard dose therapy for gastroesophageal reflux disease (GERD)-is an effective therapy for uncomplicated GERD in systemic sclerosis (SSc) but there is no data of response rate of standard dose of PPI and predictors of PPI-partial response (PPI-PR) GERD in SSc.Objectives of the study were to determine the prevalence of omeprazole partial response GERD in SSc and to define the predictors of PPI-PR GERD in SSc. Adult SSc patients having GERD were treated with omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks. Severity of symptom-grading by visual analogue scale (VAS) and frequency of symptoms by frequency scale for symptoms of GERD (FSSG) were assessed at baseline and 4 weeks after treatment. PPI-PR GERD was defined by less than 50% improvement in VAS of severity of symptom and acid reflux score by FSSG after treatment compare to baseline.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. SSc patients aged between 18 and 65 years.
2. Clinically diagnosed as GERD
3. Must not receive any 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

proton pump inhibitor

Experimental group

Description:

omeprazole 20 mg twice daily

Treatment:

Drug: Omeprazole 20mg