Ignite Creation Date:
2024-05-06 @ 2:28 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04329000
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2020-03-25
Brief Title:
On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barretts Esophagus
Sponsor:
Kaohsiung Veterans General Hospital
Organization:
Kaohsiung Veterans General Hospital
Study Overview
Official Title:
The Impacts of On-demand Versus Continuous Esomeprazole Therapy on the Symptom Control and Histological Changes of Metaplastic Esophageal Epithelium in Patients With Barretts Esophagus EsoBE - a Multicentre Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
On-demand PPI therapy is feasible for the long-term treatment of patients with Barretts esophagus
Detailed Description:
Consecutive patients with symptomatic Barretts 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 qd 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None