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

NCT ID: NCT02666976

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ilaprazole group

ilaprazole 20mg once daily for 4 weeks.

Group Type: EXPERIMENTAL

Ilaprazole

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Older than 20 years old and younger than 80 years old
• Patients with typical reflux symptoms at least 2days per week (or GERD Q score ≥ 8 )
• No erosion at GE junction through endoscopy
• Patients that can perform a 24 hr - combined multichannel intraluminal impedance and pH esophageal monitoring prior to this study.

Exclusion Criteria

• included prior history of documented intolerance of ilaprazole or similar PPIs, or
• unsuspected alarm symptoms such as weight loss, hematemesis, hematochezia, jaundice or other significant illness like malignancy
• alcoholism or drug addiction
• uncontrolled diabetes, cerebrovascular accident or diseases needed an operation in the last 3 months before enrollment
• any previous esophageal surgery
• malignancy in gastrointestinal tract within 5years
• pregnant woman
• Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal motility abnormality, esophageal stricture, duodenal ulcer, gastric ulcer, pancreatitis, absorption disorder, severe cardiovascular disease, severe lung disease in the last 3 months before enrollment
• history of steadily taking medicine such as diazepam, quinidine, diphenylhydantoin, mephenytoin, warfarin, anticholinergic, prostaglandin analog, antineoplastic agent, salicylate, steroid, pro-motility drug, nonsteroidal anti-inflammatory drugs(NSAIDS)
• patients who were registered other exams within 28days
• patients who could not conduct sedated endoscopy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2014-0110

Identifier Type: -

Identifier Source: org_study_id