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

Gastrointestinal Subepithelial Tumors Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666976
• Other study ID #: 4-2014-0110
• Status: Completed
• Phase: Phase 4
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Subepithelial Tumors

Intervention

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-a, IL-8, IL-1ß, TRPV1 and MCP-1) were accessed.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of symptoms	All patients complete the GerdQ questionnaire before and after taking ilaprazole. It was utilized to assess improvement of symptoms after taking medicine.	4 weeks
Secondary	changes of histopathological findings	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-a, IL-8, IL-1ß, TRPV1 and MCP-1) were also accessed by RT-PCR.	4 weeks
Secondary	changes of inflammatory biomarkers	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-a, IL-8, IL-1ß, TRPV1 and MCP-1) were also accessed by RT-PCR.	4 weeks