NCT03561233

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Systemic Sclerosis
• Gastroesophageal Reflux
• Proton Pubm Inhibitor

Interventions

Type	Name	Description
DRUG	Omeprazole 20mg	omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks

Timeline

• Start date: 2013-05-01
• Primary completion: 2018-05-01
• Completion: 2018-06-01
• First posted: 2018-06-19
• Last updated: 2018-06-21