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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-02

Study Completion Date

2019-12-08

Brief Summary

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

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Detailed Description

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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

Conditions

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Barrett Esophagus Proton Pump Inhibitor Symptom Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized-controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Esomeprazole 40mg

Intervention Type DRUG

On-demand Esomeprazole 40 mg QD

Continuous PPI therapy

The patients in this group were advised to take PPI QD continuously for 48 weeks.

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

Continuous Esomeprazole 40 mg QD

Interventions

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Esomeprazole 40mg

On-demand Esomeprazole 40 mg QD

Intervention Type DRUG

Esomeprazole

Continuous Esomeprazole 40 mg QD

Intervention Type DRUG

Other Intervention Names

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nexium 40 mg nexium 40 mg

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No