NCT02666976

The Prospective Study on the Effect of Ilaprazole in Non-erosive Reflux Disease Patients; Focused on Histologic Findings and Inflammatory Biomarker

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Non-erosive reflux disease (NERD) patients used to be less responsive to proton pump inhibitor (PPI)s as compared with patients with erosive esophagitis. The aim of this study is to objectively evaluate the effect of a new PPI, ilaprazole in NERD for adjusting the focus of symptom score, histopathologic findings and inflammatory biomarker. A prospective study performed at single hospital enrolled 20 patients who were diagnosed clinically as NERD. Patients underwent EGD, a 24hr-combined multichannel intraluminal impedance and pH esophageal monitoring (MII-pH) and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) will be accessed.

Conditions

• Gastrointestinal Subepithelial Tumors

Interventions

Type	Name	Description
DRUG	Ilaprazole	Patients who were diagnosed clinically as NERD and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were accessed.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-08-01
• Completion: 2016-01-01
• First posted: 2016-01-28
• Last updated: 2019-03-22

Locations

1 site across 1 country: South Korea