On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.

April 1, 2020 updated by: Sung-shuo Kao, Kaohsiung Veterans General Hospital.

The Impacts of On-demand Versus Continuous Esomeprazole Therapy on the Symptom Control and Histological Changes of Metaplastic Esophageal Epithelium in Patients With Barrett's Esophagus (EsoBE) - a Multicentre Randomized Controlled Trial

On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.

Study Overview

Detailed Description

Consecutive patients with symptomatic Barrett's esophagus are recruited and receive biopsy for esophageal metaplastic mucosa and gastric mucosa over the antrum and body during endoscopy on enrollment. The biopsy protocol for esophageal metaplastic mucosa is following Seattle protocol. GERD Q score will be conducted on enrollment. Additionally, blood sampling for CYP2C19 genotyping is also conducted on enrollment. The eligible subjects will be treated by 8-week esomeprazole, and are then randomly assigned to receive either maintenance or on-demand esomeprazole therapy (40 mg q.d.) for 40 weeks. The patients were asked to come back every four weeks for the recording of symptom days and PPI tablet consumption numbers. Follow-up endoscopy with biopsy for esophageal and gastric mucosa is performed at the end of the 48th weeks. We will compare the effects of maintenance and on-demand PPI therapy on (1) histological changes of esophageal metaplastic mucosa (2) symptom control (3) tablet consumption number

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients between the ages of 20 and 80 years
  • having symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach
  • having Barrett's Esophagus proven by histology confirmation
  • length of esophageal metaplastic mucosa equal to or longer than 1 centimeter

Exclusion Criteria:

  • pregnancy,
  • coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia)
  • previous gastric surgery,
  • allergic to esomeprazole,
  • presence of dysplastic esophageal mucosa
  • equivocal endoscopic diagnosis of Barrett's esophagus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: On-demand PPI therapy
The patients in this group were advised to take PPI for 8 weeks continuously, followed by on-demand PPI therapy for the following 40 weeks.
On-demand Esomeprazole 40 mg QD
Other Names:
  • nexium 40 mg
ACTIVE_COMPARATOR: Continuous PPI therapy
The patients in this group were advised to take PPI QD continuously for 48 weeks.
Continuous Esomeprazole 40 mg QD
Other Names:
  • nexium 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of progression, remaining unchanged, or regression of the distal esophageal metaplastic mucosa in both groups after 48 weeks
Time Frame: 48 weeks.
Progression, stationary, regression
48 weeks.
Total symptom day
Time Frame: 48 weeks
Days with reflux symptoms
48 weeks
Number of tablets consumed
Time Frame: 48 weeks
PPI tablets consumed during follow-up
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: SUNG-SHUO KAO, Bachelor, Kaohsiung Veterans General Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 2, 2010

Primary Completion (ACTUAL)

February 13, 2019

Study Completion (ACTUAL)

December 8, 2019

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 28, 2020

First Posted (ACTUAL)

April 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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