- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04329000
On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.
April 1, 2020 updated by: Sung-shuo Kao, Kaohsiung Veterans General Hospital.
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
On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
218
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
On-demand Esomeprazole 40 mg QD
Other Names:
|
ACTIVE_COMPARATOR: Continuous PPI therapy
The patients in this group were advised to take PPI QD continuously for 48 weeks.
|
Continuous Esomeprazole 40 mg QD
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
48 weeks.
|
Total symptom day
Time Frame: 48 weeks
|
Days with reflux symptoms
|
48 weeks
|
Number of tablets consumed
Time Frame: 48 weeks
|
PPI tablets consumed during follow-up
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: SUNG-SHUO KAO, Bachelor, Kaohsiung Veterans General Hospital.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kahrilas PJ. Clinical practice. Gastroesophageal reflux disease. N Engl J Med. 2008 Oct 16;359(16):1700-7. doi: 10.1056/NEJMcp0804684.
- Vakil 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.
- Attwood 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.
- Kastelein 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.
- Laine 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.
- Sharma 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.
- Gatenby 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 2, 2010
Primary Completion (ACTUAL)
February 13, 2019
Study Completion (ACTUAL)
December 8, 2019
Study Registration Dates
First Submitted
March 25, 2020
First Submitted That Met QC Criteria
March 28, 2020
First Posted (ACTUAL)
April 1, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 3, 2020
Last Update Submitted That Met QC Criteria
April 1, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VGHKSBE01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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