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Diagnosis of Acid Reflux Disease Using Novel Imaging: A Prospective Study

NCT02081404 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-03-16

No results posted yet for this study

Summary

Gastroesophageal reflux disease (GERD), a common chronic disorder in the veteran population, is associated with drug costs exceeding $ 10 billion/year. Only 30-40% of patients with reflux symptoms have erosive esophagitis. The vast majority suffers from non erosive reflux disease (NERD), a condition in which standard endoscopy fails to identify any mucosal breaks and is unable to confirm the diagnosis. Unfortunately, a gold standard for the diagnosis of NERD does not exist. Narrow band imaging (NBI) utilizes spectral narrow band filters (incorporated into standard endoscopes) and helps to see abnormal areas not identified during standard endoscopy. Preliminary results have shown that NBI endoscopy may represent a significant improvement over standard endoscopy for the diagnosis of NERD. The purpose of this study is to accurately diagnosis non acid reflux disease by using a blue light (also known as NBI)upper endoscopy technique.

Conditions

  • Non-erosive Reflux Disease

Interventions

DRUG

Esomeprazole

standard dose of proton pump inhibitor by mouth once a day for 30 days

DRUG

Placebo

placebo

Sponsors & Collaborators

  • Kansas City Veteran Affairs Medical Center

    collaborator FED

  • Midwest Biomedical Research Foundation

    lead OTHER

Principal Investigators

  • Prateek Sharma, M.D. · VA Office of Research and Development

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-01
Primary Completion
2020-01-05
Completion
2020-08-05

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02081404 on ClinicalTrials.gov