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
1 other identifier
interventional
218
0 countries
N/A
Brief Summary
On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2019
CompletedFirst Submitted
Initial submission to the registry
March 25, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedApril 3, 2020
March 1, 2020
9 years
March 25, 2020
April 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rates of progression, remaining unchanged, or regression of the distal esophageal metaplastic mucosa in both groups after 48 weeks
Progression, stationary, regression
48 weeks.
Total symptom day
Days with reflux symptoms
48 weeks
Number of tablets consumed
PPI tablets consumed during follow-up
48 weeks
Study Arms (2)
On-demand PPI therapy
EXPERIMENTALThe patients in this group were advised to take PPI for 8 weeks continuously, followed by on-demand PPI therapy for the following 40 weeks.
Continuous PPI therapy
ACTIVE COMPARATORThe patients in this group were advised to take PPI QD continuously for 48 weeks.
Interventions
On-demand Esomeprazole 40 mg QD
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (7)
Kahrilas PJ. Clinical practice. Gastroesophageal reflux disease. N Engl J Med. 2008 Oct 16;359(16):1700-7. doi: 10.1056/NEJMcp0804684.
PMID: 18923172BACKGROUNDVakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
PMID: 16928254BACKGROUNDAttwood SE, Lundell L, Hatlebakk JG, Eklund S, Junghard O, Galmiche JP, Ell C, Fiocca R, Lind T. Medical or surgical management of GERD patients with Barrett's esophagus: the LOTUS trial 3-year experience. J Gastrointest Surg. 2008 Oct;12(10):1646-54; discussion 1654-5. doi: 10.1007/s11605-008-0645-1. Epub 2008 Aug 16.
PMID: 18709511BACKGROUNDKastelein F, Spaander MC, Steyerberg EW, Biermann K, Valkhoff VE, Kuipers EJ, Bruno MJ; ProBar Study Group. Proton pump inhibitors reduce the risk of neoplastic progression in patients with Barrett's esophagus. Clin Gastroenterol Hepatol. 2013 Apr;11(4):382-8. doi: 10.1016/j.cgh.2012.11.014. Epub 2012 Nov 28.
PMID: 23200977BACKGROUNDLaine L, Ahnen D, McClain C, Solcia E, Walsh JH. Review article: potential gastrointestinal effects of long-term acid suppression with proton pump inhibitors. Aliment Pharmacol Ther. 2000 Jun;14(6):651-68. doi: 10.1046/j.1365-2036.2000.00768.x.
PMID: 10848649BACKGROUNDSharma P, Dent J, Armstrong D, Bergman JJ, Gossner L, Hoshihara Y, Jankowski JA, Junghard O, Lundell L, Tytgat GN, Vieth M. The development and validation of an endoscopic grading system for Barrett's esophagus: the Prague C & M criteria. Gastroenterology. 2006 Nov;131(5):1392-9. doi: 10.1053/j.gastro.2006.08.032. Epub 2006 Aug 16.
PMID: 17101315BACKGROUNDGatenby PA, Ramus JR, Caygill CP, Shepherd NA, Watson A. Relevance of the detection of intestinal metaplasia in non-dysplastic columnar-lined oesophagus. Scand J Gastroenterol. 2008;43(5):524-30. doi: 10.1080/00365520701879831.
PMID: 18415743BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SUNG-SHUO KAO, Bachelor
Kaohsiung Veterans General Hospital.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 25, 2020
First Posted
April 1, 2020
Study Start
February 2, 2010
Primary Completion
February 13, 2019
Study Completion
December 8, 2019
Last Updated
April 3, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share