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Completed

NCT Number: NCT04329000

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

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

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Key information

Conditions

Barrett Esophagus Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Neoplasms Precancerous Conditions Proton Pump Inhibitor Reflux Symptom

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole 40mg

Drug

On-demand Esomeprazole 40 mg QD

Other names: nexium 40 mg

Esomeprazole

Drug

Continuous Esomeprazole 40 mg QD

Other names: nexium 40 mg

Primary outcomes

  1. 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

  2. Total symptom day

    Time frame: 48 weeks

    Days with reflux symptoms

  3. Number of tablets consumed

    Time frame: 48 weeks

    PPI tablets consumed during follow-up

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Apr 1, 2020
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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