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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02666976
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 18
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Subepithelial Tumors	Drug: Ilaprazole	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: ilaprazole group ilaprazole 20mg once daily for 4 weeks.

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.

Outcome Measures

Primary Outcome Measures

1. Changes of symptoms [4 weeks]

   All patients complete the GerdQ questionnaire before and after taking ilaprazole. It was utilized to assess improvement of symptoms after taking medicine.

Secondary Outcome Measures

1. changes of histopathological findings [4 weeks]

   Changes of histopathological findings and inflammatory biomarkers will be assessed before and after treatment. Histologic findings include basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte. Inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were also accessed by RT-PCR.

2. changes of inflammatory biomarkers [4 weeks]

   Changes of histopathological findings and inflammatory biomarkers will be assessed before and after treatment. Histologic findings include basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte. Inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were also accessed by RT-PCR.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02666976
• Other Study ID Numbers: 4-2014-0110
• First Posted: Jan 28, 2016
• Last Update Posted: Mar 22, 2019
• Last Verified: Jan 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Yonsei University: Gastroesophageal reflux, proton pump inhibitors, ilaprazole

Study Results

No Results Posted as of Mar 22, 2019