Trials / Completed
CompletedNCT04329000
On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 218 (actual)
- Sponsor
- Kaohsiung Veterans General Hospital. · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esomeprazole 40mg | On-demand Esomeprazole 40 mg QD |
| DRUG | Esomeprazole | Continuous Esomeprazole 40 mg QD |
Timeline
- Start date
- 2010-02-02
- Primary completion
- 2019-02-13
- Completion
- 2019-12-08
- First posted
- 2020-04-01
- Last updated
- 2020-04-03
Source: ClinicalTrials.gov record NCT04329000. Inclusion in this directory is not an endorsement.