Trial | NCT03561233  Report issue

Official Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    250
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.
Study Started
May 31
2013
Primary Completion
May 31
2018
Study Completion
Jun 30
2018
Last Update
Jun 21
2018

Drug Omeprazole 20mg

omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks

proton pump inhibitor Experimental

omeprazole 20 mg twice daily

Criteria 

Inclusion Criteria:

SSc patients aged between 18 and 65 years.
Clinically diagnosed as GERD
Must not receive any 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
No Results Posted