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

Primary Purpose

Barrett Esophagus, Proton Pump Inhibitor, Symptom

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Esomeprazole 40mg
Esomeprazole
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barrett Esophagus focused on measuring Barrett's Esophagus, Erosive esophagitis, Proton pump inhibitor, On-demand therapy, Continuous therapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    On-demand PPI therapy

    Continuous PPI therapy

    Arm Description

    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.

    The patients in this group were advised to take PPI QD continuously for 48 weeks.

    Outcomes

    Primary Outcome Measures

    Rates of progression, remaining unchanged, or regression of the distal esophageal metaplastic mucosa in both groups after 48 weeks
    Progression, stationary, regression
    Total symptom day
    Days with reflux symptoms
    Number of tablets consumed
    PPI tablets consumed during follow-up

    Secondary Outcome Measures

    Full Information

    First Posted
    March 25, 2020
    Last Updated
    April 1, 2020
    Sponsor
    Kaohsiung Veterans General Hospital.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04329000
    Brief Title
    On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.
    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 Barrett's Esophagus (EsoBE) - a Multicentre Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2, 2010 (Actual)
    Primary Completion Date
    February 13, 2019 (Actual)
    Study Completion Date
    December 8, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kaohsiung Veterans General Hospital.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Barrett Esophagus, Proton Pump Inhibitor, Symptom, Reflux
    Keywords
    Barrett's Esophagus, Erosive esophagitis, Proton pump inhibitor, On-demand therapy, Continuous therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized-controlled trial
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    218 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    On-demand PPI therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Continuous PPI therapy
    Arm Type
    Active Comparator
    Arm Description
    The patients in this group were advised to take PPI QD continuously for 48 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Esomeprazole 40mg
    Other Intervention Name(s)
    nexium 40 mg
    Intervention Description
    On-demand Esomeprazole 40 mg QD
    Intervention Type
    Drug
    Intervention Name(s)
    Esomeprazole
    Other Intervention Name(s)
    nexium 40 mg
    Intervention Description
    Continuous Esomeprazole 40 mg QD
    Primary Outcome Measure Information:
    Title
    Rates of progression, remaining unchanged, or regression of the distal esophageal metaplastic mucosa in both groups after 48 weeks
    Description
    Progression, stationary, regression
    Time Frame
    48 weeks.
    Title
    Total symptom day
    Description
    Days with reflux symptoms
    Time Frame
    48 weeks
    Title
    Number of tablets consumed
    Description
    PPI tablets consumed during follow-up
    Time Frame
    48 weeks

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SUNG-SHUO KAO, Bachelor
    Organizational Affiliation
    Kaohsiung Veterans General Hospital.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18923172
    Citation
    Kahrilas PJ. Clinical practice. Gastroesophageal reflux disease. N Engl J Med. 2008 Oct 16;359(16):1700-7. doi: 10.1056/NEJMcp0804684.
    Results Reference
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    PubMed Identifier
    16928254
    Citation
    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.
    Results Reference
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    PubMed Identifier
    18709511
    Citation
    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.
    Results Reference
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    PubMed Identifier
    23200977
    Citation
    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.
    Results Reference
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    PubMed Identifier
    10848649
    Citation
    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.
    Results Reference
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    PubMed Identifier
    17101315
    Citation
    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.
    Results Reference
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    PubMed Identifier
    18415743
    Citation
    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.
    Results Reference
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    On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.

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