NCT02666976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
Last Updated

March 22, 2019

Status Verified

January 1, 2016

Enrollment Period

1.1 years

First QC Date

January 24, 2016

Last Update Submit

March 20, 2019

Conditions

Gastrointestinal Subepithelial Tumors

Keywords

Gastroesophageal reflux, proton pump inhibitors, ilaprazole

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • changes of histopathological findings

    4 weeks

  • changes of inflammatory biomarkers

    4 weeks

Study Arms (1)

ilaprazole group

EXPERIMENTAL

ilaprazole 20mg once daily for 4 weeks.

Drug: Ilaprazole

Interventions

IlaprazoleDRUG

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.

ilaprazole group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

ilaprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2016

First Posted

January 28, 2016

Study Start

July 1, 2014

Primary Completion

August 1, 2015

Study Completion

January 1, 2016

Last Updated

March 22, 2019

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)